Hydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvapta
- Conditions
- 1003836010029149Autosomal dominant polycystic kidney diseasepolycystic kidney disease
- Registration Number
- NL-OMON46358
- Lead Sponsor
- efrologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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
1. 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)
2. a. Patients taking medication likely to confound endpoint assessments (e.g. NSAID or diuretics such as furosemide or spironolactone)
2. b. Patients having concomitant illnesses likely to confound endpoint assessments such (e.g. diabetes mellitus for which medication is needed or diabetes insipidus)
3. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome variable will be change in 24-hour urine volume as a<br /><br>percentage, comparing the mean of the volumes collected at the end of the<br /><br>placebo treatment period with the mean of the two volumes collected at the end<br /><br>of the two-week treatment periods with hydrochlorothiazide and metformin.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Change in glomerular filtration rate (as measured with the iohexol plasma<br /><br>clearance technique)<br /><br>-Change in plasma copeptin<br /><br>-Tolerability of the study medication </p><br>