Dapagliflozin to slow kidney decline in autosomal dominant polycystic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial that will enroll 420 adults with rapidly progressing autosomal dominant polycystic kidney disease to receive dapagliflozin 10 mg daily or matching placebo. The primary outcome is the chronic eGFR slope over follow-up, and a secondary composite endpoint includes a 40% eGFR loss, kidney failure, or renal death. Safety will be monitored with an interim analysis including total kidney volume, eGFR, and copeptin levels. Key exclusions include recent use of tolvaptan, SGLT2 inhibitors, somatostatin analogues, or certain serious infections and diabetes types that confer higher risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female patients with ADPKD (modified Ravine criteria) ≥ 18 and ≤ 60 years
* Patients 18 - 39 years: eGFR ≥25 ml/min; patients 40 - 60 years: eGFR ≥25 and \<90 ml/min/1.73 m2
* Indicators of rapid progression, either of the following:
* Mayo class 1D-E
* Mayo class 1C AND EITHER

  1. Truncating PKD1 mutation OR
  2. eGFR loss \> 3ml/min/year (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR
  3. PROPKD score \> 6 (patient history)
* IF patient is on ACE-I /ARBs: stable dose for 4 weeks before screening

Exclusion Criteria:

* Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening
* Medical history of diabetic ketoacidosis, necrotizing fasciitis or organ transplantation
* Diabetes mellitus type 1 or any type of diabetes mellitus due to insulin deficiency
* Uncontrolled ongoing urinary tract or genital infections
* Known intolerance of the study medication ingredients
* Uncontrolled grade 2 hypertension (\>160/100 mmHg)
* Symptomatic hypotension, or systolic blood pressure \<90 mmHg
* Primary renal disease other than ADPKD
* Hepatic impairment (aspartate transaminase \[AST\] or alanine transaminase \[ALT\]\>3x the up-per limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment)
* Pregnancy, breastfeeding or women of child-bearing potential not using effective contraception method
* Not able to comply with the study protocol, in the investigator's judgement
* Not able to provide informed consent
* Participation in any other interventional clinical trial in the last 2 months

Where it's running

• Vorarlberger Krankenhaus-Betriebsgesellschaft
  Feldkirch, Austria Recruiting
• Medizinische Universitaet Innsbruck
  Innsbruck, Austria Recruiting
• Robert Bosch Gesellschaft für Medizinische Forschung mbH
  Stuttgart, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Aachen AöR
  Aachen, Germany Recruiting
• Charite Universitaetsmedizin Berlin KöR
  Berlin, Germany Recruiting
• Universitätsklinikum Köln
  Cologne, Germany Recruiting

Study contacts

• Study coordinator: Roman-Ulrich Müller, Prof.
• Email: STOP-PKD@uk-koeln.de
• Phone: +49221478191005

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease

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• National Registry for Rare Kidney Diseases

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• Using Metformin to Slow Kidney Decline in Polycystic Kidney Disease

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• Evaluating biomarkers in early autosomal dominant polycystic kidney disease

  This study is trying to see if certain biomarkers can help understand how severe early autosomal dominant polycystic kidney disease is for young patients aged 15 to 40.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04630613

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.