STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease (STOP-PKD)

May 28, 2026 updated by: Roman Müller, University of Cologne
Autosomal dominant polycystic kidney disease is the most common genetic cause of kidney failure. The only approved treatment for ADPKD - tolvaptan - is limited in its use by massive therapy-associated polyuria. This trial tests if the SGLT2-inhibitor dapagliflozin slows down the loss of kidney function in ADPKD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

ADPKD is a genetic disease characterized by the growth of fluid-filled renal cysts, leading to progressive loss of kidney function. SGLT2- inhibitors have recently become available for the treatment of chronic kidney disease (CKD). The landmark trials, which proved the positive effect of SGLT2-inhibitors in CKD, excluded patients with ADPKD. Accordingly, current ADPKD-guidelines do not recommend the use of SGLT2-inhibitors in ADPKD.

This investigator-driven, randomized, placebo-controlled, multi-center, double-blind trial will assess the effect of daily dapagliflozin (10mg) intake on the chronic eGFR-slope in 420 patients with ADPKD. As a secondary endpoint the study will assess a composite endpoint triggered by reaching either 40%-eGFR loss, kidney failure or renal death. Safety aspects will additionally be addressed by an interim safety analysis considering total kidney volume, eGFR and copeptin-levels.

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Matching Placebo
Participants receive a matching placebo orally once daily for 36 months.
Experimental: Dapagliflozin 10 mg
Drug: Dapagliflozin 10 mg
Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic eGFR slope
Time Frame: week 6 up to week 156 (end of treatment)
The annual chronic eGFR slope will be calculated using all available serum creatinine values from week 6 to week 156 (end of treatment), using linear mixed models.
week 6 up to week 156 (end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in eGFR from pre-treatment to post-treatment (off-treatment values)
Time Frame: Week -4 to Week 168
Change in kidney function will be assessed by comparing the mean eGFR values before treatment (calculated as the average of serum creatinine measurements at week -4 and week 0) with the mean eGFR values after treatment (calculated as the average of measurements at week 162 and week 168). The difference between these two timepoints represents the off-treatment change in kidney function.
Week -4 to Week 168
Time to first occurrence of a composite renal endpoint
Time Frame: From randomization (week 0) until end of follow-up (up to week 168)

Time from randomization to the first occurrence of any of the following events:

  1. A sustained ≥40% decrease in eGFR from randomization, confirmed by a second measurement at the next scheduled visit or measured at the last scheduled visit before death or study end.
  2. End-stage kidney disease (ESKD), defined as initiation of chronic dialysis, kidney transplantation, or a sustained eGFR <15 mL/min/1.73 m².
  3. Renal death.
From randomization (week 0) until end of follow-up (up to week 168)
Incidence of serious adverse events (SAEs)
Time Frame: From randomization (week 0) until end of follow-up (week 168)
All serious adverse events (SAEs) will be collected.
From randomization (week 0) until end of follow-up (week 168)
Incidence of adverse events of special interest (AESIs)
Time Frame: From randomization (week 0) until end of follow-up (week 168)
All adverse events of special interest (AESIs) will be collected.
From randomization (week 0) until end of follow-up (week 168)
Change in total kidney volume (TKV) after 1 year
Time Frame: Baseline (week -4 until week 0) to week 48 (first 150 patients)
In the first 150 enrolled participants, total kidney volume (TKV) will be measured at baseline and at week 48 using standardized MRI protocols. The change in TKV over 48 weeks will be used to assess potential effects of dapagliflozin on kidney size.
Baseline (week -4 until week 0) to week 48 (first 150 patients)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in kidney function based on cystatin-C measurements
Time Frame: week -4 until EOS (week 168)

Annual slopes of eGFR decline (in mL/min/1,73m2 per year), as calculated with linear mixed models using all available cystatin-c values:

  1. on-treatment between week 6 and EOT (week 156)
  2. off-treatment: before treatment (week -4 and week 0) and after treatment (week 162 and week 168)
  3. between baseline and EOT (week 0-156)
week -4 until EOS (week 168)
Changes in albuminuria
Time Frame: from randomization (week 0) until EOT (week 156)
Worsening (increase >50% in comparison to baseline) or new onset of albuminuria (defined as >30mg albumin/g creatinine)
from randomization (week 0) until EOT (week 156)
Incidence of kidney stones
Time Frame: from randomization (week 0) until EOS (week 168)
Number of symptomatic kidney stones (number of symptomatic episodes)
from randomization (week 0) until EOS (week 168)
Total eGFR slope
Time Frame: from randomization (week 0) until week 156
Total slope: annual slope of eGFR decline (in mL/min/1,73m2 per year), as calculated with linear mixed models, using all available creatinine values from baseline until end of treatment (week 0-156)
from randomization (week 0) until week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

May 15, 2030

Study Completion (Estimated)

May 15, 2030

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-5522
  • 2025-521276-59-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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