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Tolvaptan Open Label


Title A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease
Therapeutic Area Polycystic Kidney Disease
Principal Investigator Ronald Perrone, MD
Min Age 18 Years
Max Age 60 Years
Gender Both
Contact Elise Hoover
617-636-7914
More Information https://clinicaltrials.gov/ct2/show/NCT02251275

Overview

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, and have participated in a previous Tolvaptan research study, you may want to learn more about the Open Label clinical research study.

What is the Open Label study?

The purpose of the Open Label study is to evaluate the long-term safety and effectiveness of an investigational medication called tolvaptan in patients with ADPKD.

Who can participate?

You may be able to join the study if you:

  • Have participated in a previous Tolvaptan research study
  • 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
  • Previous participation in a Tolvaptan research study

Exclusion Criteria

  • Kidney transplant or dialysis

Study Requirements

Participation in the Open Label study will last up until the drug is approved by the FDA for prescription use in treating ADPKD.

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 monthly to have study-related tests and procedures.