Polycystic Kidney, Autosomal Dominant Clinical Trial
— WATEROfficial title:
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | October 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 1. Diagnosis of ADPKD (ravine criteria/documented by nephrologist) 2. 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. 3. Age >= 18 years. 4. eGFR >30 ml/min/1.73m2. 5. Providing informed consent. 6. Compliance to the recommended diet at two consecutive times. Exclusion criteria: 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: - 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
Esther Meijer |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline, week 2, week 4, week 6, week 8. | |
Secondary | mGFR | 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. | |
Secondary | Blood pressure | 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. | |
Secondary | 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. | Baseline, week 2, week 4, week 6, week 8. | |
Secondary | 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. | Baseline, week 2, week 4, week 6, week 8. |
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