No registrations found.
ID
Source
Brief title
Health condition
ADPKD
cystenieren
polycystic kidney disease
polyuria
polyurie
tolvaptan
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome variable will be change in 24-hour urine volume
Secondary outcome
-Change in glomerular filtration rate (as measured with the iohexol plasma clearance technique)
-Change in plasma copeptin
-Tolerability of the study medication
Study objective
Metformin and hydrochlorothiazide attenuate polyuria in patients treated with tolvaptan
Study design
BL visit
2 week visit
5 week visit
8 week visit
Intervention
Subjects will be treated with hydrochlorothiazide, metformin and placebo for two weeks each, followed by one wash-out week, in random order. Hydrochlorothiazide will be initiated at 12,5mg QD, after one week the dose will be increased to 25mg QD if well tolerated. Metformin will be initiated at 500mg BID, after one week the dose will be increased to 1000mg BID, if well tolerated.
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6546 |
| NTR-old | NTR6734 |
| CCMO | NL2017HCTMet |