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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2030-05-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Kidney, Autosomal Dominant

Keywords

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STOP-PKD ADPKD Dapagliflozin SGLT2 PKD polycystic kidney disease SGLT2i sodium-glucose sodium glucose Phase 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase III, investigator-driven, multi-center, randomized, placebo-controlled, double-blind

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dapagliflozin 10 mg

Group Type EXPERIMENTAL

Dapagliflozin 10 mg

Intervention Type DRUG

Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.

Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Participants receive a matching placebo orally once daily for 36 months.

Interventions

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Dapagliflozin 10 mg

Participants receive 10 mg of Dapagliflozin orally once daily for 36 months.

Intervention Type DRUG

Matching Placebo

Participants receive a matching placebo orally once daily for 36 months.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Roman Müller

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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