Clinical trials›Chronic Kidney Disease›Oral›Trial details
FinishedComing Soon (1–3 yrs) Treatment Study

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

For Condition: Chronic Kidney Disease

ID: NCT03036150

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Pills / Oral Tablets
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Read Full Scientific Objectives & Methods

This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (CKD) or cardiovascular (CV)/renal death.

Study Timeline & Quick Facts
Trial Status
Study Finished
Total Target Enrollment
4.3K patients (Actual)
Study Start Date
2017-02-02
Est. Primary Completion
2020-06-12
Tested Drugs & Treatment Groups
DRUGDapagliflozin (Farxiga)

10 mg or 5 mg tablets given once daily, per oral use.

DRUGPlacebo

Placebo matching dapagliflozin 10 mg or 5 mg

Treatment Arms Description

EXPERIMENTALDapagliflozin

Patients will be randomized 1:1 to either dapagliflozin or placebo.

PLACEBO_COMPARATORPlacebo

Placebo matching dapagliflozin.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 18 Years and 130 Years
Full Criteria Checklist
Who Can Join
  • Provision of signed informed consent prior to any study specific procedures
  • Female or male aged ≥18 years at the time of consent
  • eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
  • Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
  • Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,
Who Cannot Join
  • Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
  • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
  • History of organ transplantation
  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
  • Type 1 diabetes mellitus
  • New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
  • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
What is this Study Measuring?

Primary Outcome Measures

  • Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. — Time Frame: Up to 38.2 months

    End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

View Secondary Outcome Measures (3)
  • Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. — Time Frame: Up to 38.2 months

    End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

  • Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. — Time Frame: Up to 38.2 months

    The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

  • Time to Death From Any Cause. — Time Frame: Up to 38.2 months

    The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Where to Participate

This trial is recruiting at 390 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 390 Facilities & Contact Sites
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Birmingham, Alabama, United States
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Hawaiian Gardens, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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San Dimas, California, United States
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San Ramon, California, United States
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Vista, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Boynton Beach, Florida, United States
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Boynton Beach, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Duluth, Minnesota, United States
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Omaha, Nebraska, United States
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Albany, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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New Bern, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Maumee, Ohio, United States
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Jersey Shore, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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Burke, Virginia, United States
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Manassas, Virginia, United States
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Newport News, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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CABA, Argentina
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CABA, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Mar del Plata, Argentina
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Nueve de Julio, Argentina
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Rosario, Argentina
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San Luis, Argentina
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San Miguel de Tucumán, Argentina
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San Miguel de Tucumán, Argentina
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San Nicolás, Argentina
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Santa Fe, Argentina
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Santa Rosa, Argentina
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Botucatu, Brazil
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Campinas, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Joinville, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Red Deer, Alberta, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Concord, Ontario, Canada
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Etobicoke, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Baotou, China
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Foshan, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Guiyang, China
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Jilin City, China
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Lanzhou, China
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Nanchang, China
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Nanjin, China
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Nanjing, China
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Nanning, China
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Ningbo, China
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Shanghai, China
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Shengyang, China
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Shenzhen, China
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Tianjin, China
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Wuhan, China
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Yinchuan, China
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Yueyang, China
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Aarhus, Denmark
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Gentofte Municipality, Denmark
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Herlev, Denmark
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Hillerød, Denmark
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København Ø, Denmark
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Roskilde, Denmark
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Aschaffenburg, Germany
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Bad Oeynhausen, Germany
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Frankfurt am Main, Germany
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Hanover, Germany
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Magdeburg, Germany
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München, Germany
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Münster, Germany
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Schweinfurt, Germany
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Tübingen, Germany
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Ulm, Germany
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Budapest, Hungary
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Eger, Hungary
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Gyula, Hungary
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Kistarcsa, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Velence, Hungary
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Ahmedabad, India
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Bangalore, India
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Calicut, India
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Chennai, India
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Ernākulam, India
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Hyderabad, India
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Kanpur, India
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Kolkata, India
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Lucknow, India
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Madurai, India
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Nagpur, India
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Bunkyō City, Japan
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Chiba, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Kanazawa, Japan
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Kobe, Japan
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Kumamoto, Japan
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Nagano, Japan
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Nagoya, Japan
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Neyagawa, Japan
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Niigata, Japan
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Okayama, Japan
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Ōita, Japan
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Shizuoka, Japan
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Tsu, Japan
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Tsuchiura-shi, Japan
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Ueda-shi, Japan
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Uji-shi, Japan
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Yaizu-shi, Japan
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Yokohama, Japan
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Aguascalientes, Mexico
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Cuernavaca, Mexico
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Culiacán, Mexico
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D.F, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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Mazatlán, Mexico
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Mazatlán, Mexico
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México, Mexico
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Minatitlán, Mexico
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Monterrey, Mexico
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Saltillo, Mexico
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Callao, Peru
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Chorrillos, Peru
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Ica, Peru
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Piura, Peru
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San Isidro, Peru
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San Miguel, Peru
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Bacolod, Philippines
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Cebu, Philippines
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Cebu City, Philippines
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Dasmariñas, Philippines
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Davao City, Philippines
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Iloilo City, Philippines
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Makati City, Philippines
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Marikina City, Philippines
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Quezon City, Philippines
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Bielsko-Biala, Poland
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Bochnia, Poland
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Chorzów, Poland
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Ciechanów, Poland
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Katowice, Poland
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Katowice, Poland
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Krakow, Poland
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Krakow, Poland
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Legnica, Poland
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Lodz, Poland
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Olsztyn, Poland
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Ostrowiec Świętokrzyski, Poland
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Oława, Poland
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Poznan, Poland
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Ruda Śląska, Poland
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Rzeszów, Poland
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Szczecin, Poland
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Tczew, Poland
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Chelyabinsk, Russia
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Kazan', Russia
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Kemerovo, Russia
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Kemerovo, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Omsk, Russia
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Perm, Russia
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Perm, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Tver', Russia
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Ufa, Russia
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Vladikavkaz, Russia
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Volgograd, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Ansan-si, South Korea
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Deagu, South Korea
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Goyang-si, South Korea
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Goyang-si, South Korea
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Gwangju, South Korea
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Jeonju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Uijeongbu-si, South Korea
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Wŏnju, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Barcelona, Spain
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Burela (Lugo), Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Malmö, Sweden
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Stockholm, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Cherkasy, Ukraine
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Chernivtsі, Ukraine
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Dnipro, Ukraine
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv Region, Ukraine
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Kharkiv Region, Ukraine
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Kharkiv Region, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Rivne, Ukraine
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Ternopil, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Cardiff, United Kingdom
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Glasgow, United Kingdom
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Hull, United Kingdom
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Kent, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Salford, United Kingdom
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Swansea, United Kingdom
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Bien Hoa, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Hochiminh, Vietnam
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
quadruple (participant, care_provider, investigator, outcomes_assessor)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
AstraZeneca
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Scientific Literature & Publications
  • Moedt E, Koshino A, Jongs N, Ju W, Nair V, Kretzler M, Hansen MK, Arnott CG, Wheeler DC, Rossing P, Coca SG, Hammarstedt A, Greasley PJ, Bjornstad P, Bakker SJL, Heerspink HJL. Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition. J Am Soc Nephrol. 2026 Apr 2. doi: 10.1681/ASN.0000001086. Online ahead of print.PubMed ↗
  • Heerspink HJL, Chertow GM, Rossing P, Correa-Rotter R, Sjostrom CD, Toto RD, Wheeler DC, Jongs N. Effects of Dapagliflozin on Progression of CKD According to Different Rates of Pretrial eGFR Loss. Clin J Am Soc Nephrol. 2025 Nov 1;20(11):1527-1535. doi: 10.2215/CJN.0000000810. Epub 2025 Sep 9.PubMed ↗
  • Bakker WM, Heerspink HJL, Jongs N, Correa-Rotter R, Rossing P, Toto RD, Wheeler DC, McMurray JJV, Langkilde AM, Gansevoort RT, Chertow GM, Vart P. Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD. J Am Soc Nephrol. 2026 Jan 1;37(1):101-109. doi: 10.1681/ASN.0000000776. Epub 2025 Jul 18.PubMed ↗
  • Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.PubMed ↗
  • Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.PubMed ↗
View Official Medical/Scientific Title

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease