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Medication for excessive urine production in patients treated with tolvaptan


- candidate number27988
- NTR NumberNTR6734
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-okt-2017
- Secondary IDsNL2017HCTMet 
- Public Title Medication for excessive urine production in patients treated with tolvaptan
- Scientific TitleHydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvaptan
- ACRONYMMedication for excessive urine production in patients treated with tolvaptan
- hypothesisMetformin and hydrochlorothiazide attenuate polyuria in patients treated with tolvaptan
- Healt Condition(s) or Problem(s) studiedPolycystic kidney disease (ADPKD), Polyuria, Tolvaptan
- Inclusion criteria1. 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 criteria1. Patients who, in the opinion of the investigator may present a safety risk
2. Patients who are unlikely to adequately comply to the trialí»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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-mrt-2019
- Target number of participants12
- InterventionsSubjects 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.
- 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
- TimepointsBL visit
2 week visit
5 week visit
8 week visit
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Bart J. Kramers
- CONTACT for SCIENTIFIC QUERIES Ron T. Gansevoort
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-okt-2017 - 15-okt-2017


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