Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt

Related Clinical Trial
IMPEDE-PKD Randomised Placebo-controlled Trial Daily Caloric Restriction in ADPKD To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Establishment of the Human Intestinal and Salivary Microbiota Biobank – Kidney Diseases NOX4 and Related Biomarkers in ADPKD A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN) PKD Biomarkers Study Sirolimus for Massive Polycystic Liver Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt The German ADPKD Tolvaptan Treatment Registry A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD) Statin Therapy in Patients With Early Stage ADPKD Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases – PHOENIX PKD Clinical and Translational Core Study Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD Lanreotide In Polycystic Kidney Disease Study Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease Dietary Intervention in ADPKD on Tolvaptan High Water Intake in Polycystic Kidney Disease Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease A Trial of Bardoxolone Methyl in Patients With ADPKD – FALCON Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD Tolvaptan-Octreotide LAR Combination in ADPKD Polycystic Kidney Disease Data Repository ADPKD Patient Registry Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease ADPKD Cohort Study Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD Canadian Medical Assessment of JINARC™ Outcomes Registry Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease) ADPKD Alterations in Hepatic Transporter Function Efficacy Study of Water Drinking on PKD Progression. A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study Open-Label Tolvaptan Study in Subjects With ADPKD Effects of Somatostatin on ADPKD Heart Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy Effect of the Aquaretic Tolvaptan on Nitric Oxide System Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Clinical Implications of DNA Analysis on ADPKD The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With ADPKD The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe Efficacy of Tolvaptan on ADPKD Patients Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure? Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease The ELiSA Study – Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease Somatic Mutation Biorepository Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease Repository Study of Autosomal Dominant Polycystic Kidney Disease Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Brief Title

Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt

Official Title

Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt

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.
    

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


Primary Outcome

24-hour urine volume

Secondary Outcome

 Serum copeptin levels

Condition

Polycystic Kidney, Autosomal Dominant

Intervention

Sodiumchloride

Study Arms / Comparison Groups

 Normal salt, low protein treatment period
Description:  6 grams of sodium chloride daily / Placebo

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

12

Start Date

September 7, 2020

Completion Date

October 2021

Primary Completion Date

September 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Esther Meijer, Dr., 003150 361 6161, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT04310319

Organization ID

NL2019WATER


Responsible Party

Sponsor-Investigator

Study Sponsor

Esther Meijer


Study Sponsor

Esther Meijer, Dr., Principal Investigator, Universitar Medical Centre Groningen


Verification Date

November 2020