STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Cologne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Mayo class 1D-E
Mayo class 1C AND EITHER
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dapagliflozin 10 mg
DrugParticipants receive 10 mg of Dapagliflozin orally once daily for 36 months.
Matching Placebo
DrugParticipants receive a matching placebo orally once daily for 36 months.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Dapagliflozin 10 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 1682
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)3
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)4
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)Other outcomes
1
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)2
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)3
Incidence of kidney stones
Number of symptomatic kidney stones (number of symptomatic episodes)
Time frame
from randomization (week 0) until EOS (week 168)4
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 156Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cologne
Lead sponsor
University Hospital of Cologne
Sponsor institution
German Research Foundation
Collaborator
Source ClinicalTrials.gov