Metformin and hydrochlorothiazide attenuate polyuria in patients treated with tolvaptan
ID
Bron
Verkorte titel
Aandoening
ADPKD
cystenieren
polycystic kidney disease
polyuria
polyurie
tolvaptan
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome variable will be change in 24-hour urine volume
Doel van het onderzoek
Metformin and hydrochlorothiazide attenuate polyuria in patients treated with tolvaptan
Onderzoeksopzet
BL visit
2 week visit
5 week visit
8 week visit
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL6546 |
NTR-old | NTR6734 |
CCMO | NL2017HCTMet |