Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
WATER
1 other identifier
interventional
12
1 country
1
Brief Summary
This study evaluates the effect of regulating salt and protein intake on urinevolume in patients with ADPKD treated with a vasopressine V2 receptor antagonist (V2RA). The investigators hypothesize that changing sodium and protein intake will reduce V2RA-induced polyuria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedNovember 5, 2020
November 1, 2020
12 months
March 3, 2020
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-hour urine volume
Change in 24-hour urine volume as percentage, comparing the mean of the volumes collected during baseline with the mean of the two volumes collected at the end of each treatment period.
Baseline, week 2, week 4, week 6, week 8.
Secondary Outcomes (5)
Serum copeptin levels
Baseline, week 2, week 4, week 6, week 8.
mGFR
Baseline, week 2, week 4, week 6, week 8.
Blood pressure
Baseline, week 2, week 4, week 6, week 8.
Quality of life, assesed by using the ADPKD-IS questionnaire.
Baseline, week 2, week 4, week 6, week 8.
Quality of life, assesed by using the NADIQ-questionnaire.
Baseline, week 2, week 4, week 6, week 8.
Study Arms (4)
Normal salt, low protein treatment period
OTHER6 grams of sodium chloride daily / Placebo
Normal salt, normal protein treatment period
OTHER6 grams of sodium chloride daily / 40 grams of protein daily
Low salt, low protein treatment period
OTHERDouble placebo
Low salt, normal protein treatment period
OTHERPlacebo / 40 grams of protein daily
Interventions
Subjects will receive 4 capsules containting 750 NaCl each 2dd, making a total of 6 grams NaCl per day.
Subjects will receive 2dd 40 ml of a protein beverage containing 0.5 grams of protein per ml, making a total of 40 grams of protein per day.
Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd.
Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage).
Eligibility Criteria
You may qualify if:
- Diagnosis of ADPKD (ravine criteria/documented by nephrologist)
- Stable treatment regimen of tolvaptan as part of routine clinical care in the highest dose tolerable (preferably 120 mg daily), with a urine osmolality lower than 250 mosmol/L.
- Age \>= 18 years.
- eGFR \>30 ml/min/1.73m2.
- Providing informed consent.
- Compliance to the recommended diet at two consecutive times.
You may not qualify if:
- Patients who, in the opinion of the investigator may present a safety risk.
- 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).
- a. Patients taking medication likely to confound endpoint assessments:
- lithium in any dosing regimen;
- chronic use of systemic corticosteroids in any dosage;
- chronic use of any diuretics in any dosing regimen;
- daily use of any NSAIDs in any dosing regimen;
- \. b. Patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed or diabetes insipidus).
- \. Women who are pregnant or breastfeeding. 5. Patients with a blood pressure over 160/100 mm Hg at baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Esther Meijerlead
Study Sites (1)
UMC Groningen
Groningen, 9713GZ, Netherlands
Related Publications (1)
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PMID: 39356039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esther Meijer, Dr.
Universitar Medical Centre Groningen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, nephrologist
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 17, 2020
Study Start
September 7, 2020
Primary Completion
September 1, 2021
Study Completion
October 1, 2021
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share