Polycystic Kidney, Autosomal DominantWATERNCT04310319
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
A study testing Sodiumchloride and Protein in people with Polycystic Kidney, Autosomal Dominant and ADPKD, run by Esther Meijer at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant, ADPKD, Autosomal Dominant Polycystic Kidney
- What is being tested?
- Sodiumchloride and Protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2020to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Sodiumchloride, Protein, Placebo comparator (salt), Placebo comparator (protein)
- Keywords
- ADPKD, aquaresis, Vasopressine V2 receptor antagonist, Diet
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SodiumchlorideDietary supplement
Subjects will receive 4 capsules containting 750 NaCl each 2dd, making a total of 6 grams NaCl per day.
ProteinDietary supplement
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.
Placebo comparator (salt)Dietary supplement
Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd.
Placebo comparator (protein)Dietary supplement
Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage).
| Study group | Role | What they receive |
|---|---|---|
| Normal salt, low protein treatment period | Other | 6 grams of sodium chloride daily / Placebo Receives: Dietary Supplement: Sodiumchloride; Dietary Supplement: Placebo comparator (protein) |
| Normal salt, normal protein treatment period | Other | 6 grams of sodium chloride daily / 40 grams of protein daily Receives: Dietary Supplement: Sodiumchloride; Dietary Supplement: Protein |
| Low salt, low protein treatment period | Other | Double placebo Receives: Dietary Supplement: Placebo comparator (salt); Dietary Supplement: Placebo comparator (protein) |
| Low salt, normal protein treatment period | Other | Placebo / 40 grams of protein daily Receives: Dietary Supplement: Protein; Dietary Supplement: Placebo comparator (salt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 2, week 4, week 6, week 8.
Secondary outcomes (5)
Serum copeptin levels
Change in serum copeptin levels, comparing copeptin level measured at baseline with copeptin level measured at the end of each treatment period.
Measured: Baseline, week 2, week 4, week 6, week 8.
mGFR
Change in measured GFR, comparing mGFR measured at baseline with mGFR measured at the end of each treatment period.
Measured: Baseline, week 2, week 4, week 6, week 8.
Blood pressure
Change in blood pressure, comparing blood pressure measured at baseline with blood pressure measured at the end of each treatment period.
Measured: Baseline, week 2, week 4, week 6, week 8.
Quality of life, assesed by using the ADPKD-IS questionnaire.
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.
Measured: Baseline, week 2, week 4, week 6, week 8.
Quality of life, assesed by using the NADIQ-questionnaire.
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.
Measured: Baseline, week 2, week 4, week 6, week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start7 Sep 2020
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esther Meijer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esther Meijer, University Medical Center Groningen
- Investigators
- Esther Meijer, Dr., Principal investigator, Universitar Medical Centre Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310319
- Sponsor's protocol ID
- NL2019WATER
- Acronym
- WATER
- Status last verified
- Nov 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
- ClinicalTrials.gov ID
- NCT04310319
- Acronym / sponsor ID
- WATER / NL2019WATER
- Keywords
- ADPKD, aquaresis, Vasopressine V2 receptor antagonist, Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Esther MeijerUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal salt, low protein treatment period | Other | Dietary Supplement: Sodiumchloride, Dietary Supplement: Placebo comparator (protein)6 grams of sodium chloride daily / Placebo |
| Normal salt, normal protein treatment period | Other | Dietary Supplement: Sodiumchloride, Dietary Supplement: Protein6 grams of sodium chloride daily / 40 grams of protein daily |
| Low salt, low protein treatment period | Other | Dietary Supplement: Placebo comparator (salt), Dietary Supplement: Placebo comparator (protein)Double placebo |
| Low salt, normal protein treatment period | Other | Dietary Supplement: Protein, Dietary Supplement: Placebo comparator (salt)Placebo / 40 grams of protein daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SodiumchlorideSubjects will receive 4 capsules containting 750 NaCl each 2dd, making a total of 6 grams NaCl per day. | Dietary supplement | Normal salt, low protein treatment period, Normal salt, normal protein treatment period |
| ProteinSubjects 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. | Dietary supplement | Low salt, normal protein treatment period, Normal salt, normal protein treatment period |
| Placebo comparator (salt)Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd. | Dietary supplement | Low salt, low protein treatment period, Low salt, normal protein treatment period |
| Placebo comparator (protein)Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage). | Dietary supplement | Low salt, low protein treatment period, Normal salt, low protein treatment period |
Primary outcome
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.
5 secondary outcomes
Serum copeptin levels
Time frame: Baseline, week 2, week 4, week 6, week 8.
mGFR
Time frame: Baseline, week 2, week 4, week 6, week 8.
Blood pressure
Time frame: 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.
Quality of life, assesed by using the NADIQ-questionnaire.
Time frame: Baseline, week 2, week 4, week 6, week 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 39356039St 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Meijer, Dr. principal investigator
Universitar Medical Centre Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodiumchloride and Protein in people with Polycystic Kidney, Autosomal Dominant and ADPKD, run by Esther Meijer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meijer, Dr. (003150 361 6161, esther.meijer@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urine volume (time frame: Baseline, week 2, week 4, week 6, week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.