Dietary Intervention in ADPKD on Tolvaptan

NCT03858439 | Completed

• 1 other identifier: v1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited renal disorder. Tolvaptan has been approved in Canada as a treatment for ADPKD. Tolvaptan is an arginine vasopressin receptor antagonist which has been shown to decrease the progression of ADPKD. The main side effect of this treatment is increased urine output which leads to cessation of therapy in about 20% of patients. Low solute (low sodium, low protein) diet may alleviate this side effect. This is a single arm before / after study of dietary intervention on urine output and quality of life in ADPKD patients on a stable dose of tolvaptan.

Conditions

Polyuria; Autosomal Dominant Polycystic Kidney

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour urine volume

  24-hour urine volume in ml.

  Change from baseline to 3 months

Secondary Outcomes (3)

• Change in ADPKD-IS

  Change from baseline to 3 months

• Change in Nagasaki Diabetes Insipidus Questionnaire

  Change from baseline to 3 months

• Change in urine total solute

  Change from baseline to 3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Single arm study. All participants will receive dietary intervention.

Other: Dietary

Interventions

Dietary OTHER

Low sodium, low protein dietary recommendation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen in the Hamilton Nephrology Genetics Clinic with a diagnosis of ADPKD taking tolvaptan
• Able to provide informed consent
• On maximal tolerated dose of tolvaptan for at least 3 months

You may not qualify if:

• Serum sodium \> 135 mmol/L
• Patients with evidence of non-compliance (not completing monthly blood work required while on tolvaptan therapy).
• Unlikely to continue in Hamilton Nephrology Genetics Clinic for at least 6 months (planned dialysis initiation, transplant)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Polyuria; Polycystic Kidney, Autosomal Dominant

Interventions

Diet

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single group before / after dietary intervention.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 28, 2019
• Study Start: June 6, 2019
• Primary Completion: September 24, 2021
• Study Completion: May 16, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)