CompletedNot Applicable

Dietary Intervention in ADPKD on Tolvaptan

Canada8 participantsStarted 2019-06-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Change in 24-hour urine volume

Timeframe: Change from baseline to 3 months

Trial details

NCT IDNCT03858439

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-24

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