Dietary Intervention in ADPKD on Tolvaptan

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Brief Title

Dietary Intervention in ADPKD on Tolvaptan

Official Title

Dietary Intervention in Patients With ADPKD on Tolvaptan: Urine Output and Quality of Life

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.
    

Detailed Description

      Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited renal
      disorder affecting 12.5 million persons worldwide, and impacting approximately 35,000-66,000
      Canadians. An estimated 45% to 70% of patients with ADPKD progress to end-stage renal disease
      by age 65 years.

      Tolvaptan has been approved in Canada as a treatment for ADPKD. Tolvaptan was discovered in
      Japan by Otsuka Pharmaceutical and was first approved there for ADPKD in 2014. The Health
      Canada approval of Tolvaptan is based on the results of the pivotal Phase 3 randomized,
      double-blind and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date in
      adults with ADPKD.

      The treatment of ADPKD had previously been symptomatic with the aim of reducing morbidity and
      mortality associated with disease manifestations. This changed with the publication of the
      TEMPO 3:4 trial, which proved the efficacy of the arginine vasopressin (AVP) V2 receptor
      antagonist tolvaptan in decreasing the progression of CKD. In this trial, 1445 patients with
      ADPKD eGFR > 60 were randomized to receive either placebo or tolvaptan in a split-dose
      regimen of 45 mg in the morning and 15 mg in the afternoon, up titrated to 90/30 mg as
      tolerated. The REPRISE study investigated the value of tolvaptan in 1300 patients with lower
      levels of eGFR (25-65 mL/min/1.73 m2).

      AVP plays a major role in the pathogenesis of cysts in ADPKD via cAMP stimulation. The AVP
      antagonist blocks V2 receptors in collecting ducts and therefore blocks the concentrating
      ability of the tubule. This leads to increased urine volume. Recently, it has been
      demonstrated that this increased urine volume is related to solute excretion. Therefore, it
      seems possible that dietary modification to decrease solute intake (salt, protein) would
      decrease the urine volume in patients taking tolvaptan.

      The most common side effect of AVP antagonist is increased renal water excretion which
      presents as polyuria, nocturia, increased thirst, and dry mouth. The daily urine volumes 5
      days after starting different split doses of tolvaptan (15/15, 30/0, 30/15, 30/30 mg) in a
      preliminary phase 2 study were 4 to 6 L. In the treatment of hyponatremia and heart failure
      (another indication for tolvaptan therapy), a meta-analysis found an average increase in
      water clearance of only 68 mL/h after tolvaptan treatment. This more modest increase in urine
      output may be related to the low sodium diet most of these patients should be adhering to.
    


Study Type

Interventional


Primary Outcome

Change in 24-hour urine volume

Secondary Outcome

 Change in ADPKD-IS

Condition

Polyuria

Intervention

Dietary

Study Arms / Comparison Groups

 Intervention
Description:  Single arm study. All participants will receive dietary intervention.

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

Other

Estimated Enrollment

15

Start Date

June 6, 2019

Completion Date

December 2020

Primary Completion Date

September 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Patients seen in the Hamilton Nephrology Genetics Clinic with a diagnosis of ADPKD
             taking tolvaptan

          2. Able to provide informed consent

          3. On maximal tolerated dose of tolvaptan for at least 3 months

        Exclusion Criteria:

          1. Serum sodium > 135 mmol/L

          2. Patients with evidence of non-compliance (not completing monthly blood work required
             while on tolvaptan therapy).

          3. Unlikely to continue in Hamilton Nephrology Genetics Clinic for at least 6 months
             (planned dialysis initiation, transplant)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 9055221155, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03858439

Organization ID

v1


Responsible Party

Principal Investigator

Study Sponsor

McMaster University


Study Sponsor

, , 


Verification Date

March 2020