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.
- Diagnosis with ADPKD
- Previous participation in a Tolvaptan research study
- Kidney transplant or dialysis
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.