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REPRISE Tolvaptan-placebo trial for ADPKD

Title A Phase 3b, Multi-center, Randomized-withdrawl, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease between Late Stage 2 to Early Stage 4 to Autosomal Dominant Polycystic Kidney Disease
Therapeutic Area Polycystic Kidney Disease
Principal Investigator Ronald Perrone MD
Min Age 18 Years
Max Age 65 Years
Gender Both
Contact Elise Hoover


Living with the pain, high blood pressure, and other symptoms of autosomal dominant polycystic kidney disease (ADPKD) can be overwhelming. And because ADPKD may be passed from one generation to the next, you may have seen how it has affected your family and wonder how the disease will affect you.

If you have ADPKD, you may want to learn more about the REPRISE clinical research study.

What is the REPRISE study?

The purpose of the REPRISE study is to evaluate the safety and effectiveness of an investigational medication called tolvaptan in patients with late stage 2 to early stage 4 chronic kidney disease caused by ADPKD.

Who can participate?

You may be able to join the study if you:

  • Are between the ages of 18 to 55 years old; patients aged 56 to 65 may be able to participate in some circumstances
  • Are diagnosed with ADPKD

What is the investigational medication?

Tolvaptan is being investigated in this study as a potential treatment to slow the progression of cyst growth in the kidneys of adults with ADPKD.

What are the potential risks and benefits?

Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.

The information learned from the study and your participation may help us learn about how to develop future treatment options for people with ADPKD.

Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.

Study Details

Inclusion Criteria

  • Diagnosis with ADPKD
  • GFR between 25 and 65

Exclusion Criteria

  • Kidney transplant or dialysis
  • Previous experience with the drug Tolvaptan

Study Requirements

Participation in the REPRISE study will last between approximately 15 months.

If you are eligible and agree to participate in the study, you will be required to take the investigational medication twice a day and visit the study clinic up to 25 times over 15 months to have study-related tests and procedures. Depending on your circumstances, you will be offered an opportunity to have certain study visits performed at your home.  The total amount of blood taken during the entire study will be approximately 56 teaspoons (275 mL), with a possible additional 15mL per visit for additional screening blood tests.