Autosomal dominant polycystic kidney disease
Conditions
Interventions
Product Name: Hydrochlorothiazide
Product Code: HCT
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Metformin
Pha
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of ADPKD, based upon modified Ravine criteria 2. Using tolvaptan 120mg daily 3. Age between 18 and 50 years 4. =45 eGFR (CKD-EPI) 5. Providing informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who, in the opinion of the investigator may present a safety risk 2. Patients who are unlikely to adequately comply to the trial’s procedures (due for instance to medical conditions likely to require interruption or discontinuation, history of substance abuse or non-compliance) 3. a. Patients taking medication likely to confound endpoint assessments (e.g. NSAID or diuretics such as furosemide or spironolactone) 3. b. Patients having concomitant illnesses likely to confound endpoint assessments such (e.g. diabetes mellitus for which medication is needed or diabetes insipidus) 4. Women who are pregnant or breastfeeding 5. Patients with known contra indications to the study medication such as 5. a. Hydrochlorothiazide: gout, hepatic impairment, illnesses that cause potassium loss, history of hypokalaemia, known allergy to hydrochlorothiazide 5. b. Metformin: Illnesses that can cause tissue hypoxia (e.g. recent myocardial infarction, heart failure, respiratory failure), known allergy to metformin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate whether hydrochlorothiazide or metformin can diminish aquaresis in patients with ADPKD who are treated with tolvaptan as measured by 24-hour urine volume. ;Secondary Objective: -To assess change in glomerular filtration rate (as measured with the iohexol plasma clearance technique) -To assess change in plasma copeptin -To assess tolerability of the study medication ;Primary end point(s): Change in 24-hour urine volume;Timepoint(s) of evaluation of this end point: Baseline, and the end of each 2-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in glomerular filtration rate (as measured with the iohexol plasma clearance technique) -Change in plasma copeptin -Tolerability of the study medication ;Timepoint(s) of evaluation of this end point: Baseline, and the end of each 2-week treatment period. Adverse events: during entire study period | — |
Countries
Netherlands
Contacts
Public ContactBart J. Kramers
University Medical Center Groningen
Outcome results
None listed