Clinical Trials

Thanks to research funded by the PKD Foundation, clinical trials are now exploring several new therapies for PKD. Patients wishing to participate or learn more will find specific information about the therapies below. To participate in a clinical trial, you will need to have a formal diagnosis of PKD. To learn more, click here.


Learn about potential treatments here. Learn about PKD and heart disease here.

 		 
 
       

 

Tolvaptan Clinical Trial

 

Tolvaptan Tempo 3 / 4 Trial

 

Intervention:

 Drug - Tolvaptan

Sponsors:

 Otsuka Pharmaceutical Development & Commercialization, Inc.; Otsuka Pharmaceutical Co., Ltd.

Study Phase:

 III
Status: Active; enrollment complete
Age Group: 18-50

Enrollment goal:

 1,500

Description:

 To evaluate the long-term effectiveness and safety of Tolvaptan by monitoring total kidney volume and cyst volumes by magnetic resonance imaging and measuring a composite of clinical markers in ADPKD patients.
Contact: Within North America: Kristin Cornwell at 866-712-5837 or kristin.cornwell@mayo.edu
Websites: NIH Study Details

 

A Multiple Dose Trial of Modified-release (MR) and Immediate-release (IR) Tolvaptan in Subjects with ADPKD

 

Intervention:

 Drug - Tolvaptan at different dosing periods and concentrations

Sponsors:

 Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Phase:

 II

Status:

 Not yet open for enrollment

Age Group:

18-50

Enrollment goal:

 24

Description:

 To establish pharmacologic parameter and adverse event profiles of Tolvaptan administered as the modified release formulation (MR) and compare to immediate release (IR) dose regimen.

Contact:

 Study director: Frank Czerwiec, ADPKD 285studyinfo@mmgct.com  

Websites:

 NIH Study Details

 

Study to Evaluate the Long-term Efficact and Safety of Oral Tolvaptan Tablet Regimens in Subjects with ADPKD

 

Intervention:

 Drug - Tolvaptan

Sponsors:

 Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Phase:

 III
Status: Recruiting
Age Group: 18-50

Enrollment goal:

 1,500

Description:

 To demonstrate whether Tolvaptan modifies ADPKD progression as measured by changes from baseline in totaql kidney volume (TKV) and renal functions.
Websites: NIH Study Details
 
   
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