A Phase 3 interventional study of Dapagliflozin 10 mg and Matching Placebo in Polycystic Kidney, Autosomal Dominant, sponsored by University of Cologne. Recruiting at 30 sites in 4 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by University of Cologne · Phase 3, Interventional, and Treatment
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.
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.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
This study's planned enrollment of 420 is above the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Browse Polycystic Kidney, Autosomal Dominant studies →University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Mayo class 1C AND EITHER
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dapagliflozin 10 mg
Drug: Matching Placebo
Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.
Participants receive a matching placebo orally once daily for 36 months.
Chronic eGFR slope
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.
Time frame: week 6 up to week 156 (end of treatment)
Change in eGFR from pre-treatment to post-treatment (off-treatment values)
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.
Time frame: Week -4 to Week 168
Time to first occurrence of a composite renal endpoint
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.
Time frame: From randomization (week 0) until end of follow-up (up to week 168)
Incidence of serious adverse events (SAEs)
All serious adverse events (SAEs) will be collected.
Time frame: From randomization (week 0) until end of follow-up (week 168)
Incidence of adverse events of special interest (AESIs)
All adverse events of special interest (AESIs) will be collected.
Time frame: From randomization (week 0) until end of follow-up (week 168)
Change in total kidney volume (TKV) after 1 year
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.
Time frame: Baseline (week -4 until week 0) to week 48 (first 150 patients)
Change in kidney function based on cystatin-C measurements
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)
Time frame: week -4 until EOS (week 168)
Changes in albuminuria
Worsening (increase \>50% in comparison to baseline) or new onset of albuminuria (defined as \>30mg albumin/g creatinine)
Time frame: from randomization (week 0) until EOT (week 156)
Incidence of kidney stones
Number of symptomatic kidney stones (number of symptomatic episodes)
Time frame: from randomization (week 0) until EOS (week 168)
Total eGFR slope
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)
Time frame: from randomization (week 0) until week 156
Plan to share: No
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Studies of the drug tested here: Dapagliflozin
Polycystic Kidney, Autosomal Dominant →