- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310319
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt (WATER)
November 4, 2020 updated by: Esther Meijer
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.
Study Overview
Status
Unknown
Detailed Description
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is characterized by the formation of numerous cysts in both kidneys and progressive renal function decline leading to renal replacement therapy (RRT) at a median age of 58 years.
The first (and at the moment only) drug to slow down renal function decline, is a vasopressin V2 receptor antagonist (V2RA).
This medicament slows renal function decline by 26 to 34%.
V2RA also causes aquaresis associated side-effects such as polyuria of >6 liter per day in the majority of patients.
These side-effects limit wide spread use among ADPKD-patients.
Therefore, there is a need to improve its tolerability.
While using a V2RA, urine concentrating ability is strongly diminished.
Therefore, urine volume is largely determined by total osmolar excretion.
This is a well-known fact in nephrogenic diabetes insipidus, a disease with clear pathophysiological similarities to treatment with a vasopressin V2 receptor antagonist (a defect receptor versus pharmacological blockade).
A recent study found osmolar excretion to be associated with urinary volume during V2RA treatment.
Whether a change in osmolar load changes polyuria during V2RA has not yet been investigated.
The investigators hypothesize that changing sodium and protein intake will reduce polyuria.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meijer, Dr.
- Phone Number: 003150 361 6161
- Email: esther.meijer@umcg.nl
Study Contact Backup
- Name: Iris Koorevaar, drs.
- Phone Number: 0031503614198
- Email: i.w.koorevaar@umcg.nl
Study Locations
-
-
-
Groningen, Netherlands, 9713GZ
- Recruiting
- UMC Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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;
3. b. Patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed or diabetes insipidus).
4. Women who are pregnant or breastfeeding. 5. Patients with a blood pressure over 160/100 mm Hg at baseline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Normal salt, low protein treatment period
6 grams of sodium chloride daily / Placebo
|
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 placebo beverage (identical to protein beverage).
|
OTHER: Normal salt, normal protein treatment period
6 grams of sodium chloride daily / 40 grams of protein daily
|
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.
|
OTHER: Low salt, low protein treatment period
Double placebo
|
Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage).
Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd.
|
OTHER: Low salt, normal protein treatment period
Placebo / 40 grams of protein daily
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour urine volume
Time Frame: Baseline, week 2, week 4, week 6, week 8.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum copeptin levels
Time Frame: Baseline, week 2, week 4, week 6, week 8.
|
Change in serum copeptin levels, comparing copeptin level measured at baseline with copeptin level measured at the end of each treatment period.
|
Baseline, week 2, week 4, week 6, week 8.
|
mGFR
Time Frame: Baseline, week 2, week 4, week 6, week 8.
|
Change in measured GFR, comparing mGFR measured at baseline with mGFR measured at the end of each treatment period.
|
Baseline, week 2, week 4, week 6, week 8.
|
Blood pressure
Time Frame: Baseline, week 2, week 4, week 6, week 8.
|
Change in blood pressure, comparing blood pressure measured at baseline with blood pressure measured at the end of each treatment period.
|
Baseline, week 2, week 4, week 6, week 8.
|
Quality of life, assesed by using the ADPKD-IS questionnaire.
Time Frame: Baseline, week 2, week 4, week 6, week 8.
|
Change in reported quality of life, comparing reported quality of life at baseline to reported quality of life at the end of each treatment period.
To assess quality of life, the ADPKD-IS questionnaires will be used.
|
Baseline, week 2, week 4, week 6, week 8.
|
Quality of life, assesed by using the NADIQ-questionnaire.
Time Frame: Baseline, week 2, week 4, week 6, week 8.
|
Change in reported quality of life, comparing reporter quality of life at baseline to reported quality of life at the end of each treatment period.
To assess quality of life, the NADIQ-questionnaires will be used.
|
Baseline, week 2, week 4, week 6, week 8.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esther Meijer, Dr., Universitar Medical Centre Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 7, 2020
Primary Completion (ANTICIPATED)
September 1, 2021
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (ACTUAL)
March 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Arthrogryposis
Other Study ID Numbers
- NL2019WATER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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