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.

Updated: 03/06/2013

Active, Not Recruiting

Observational	Phase I	Phase II	Phase III	Phase IV
HALT PKD Progression of PKD (HALT PKD)
Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients with ADPKD (Extension of Trial 156-04-251)
UAB Recessive PKD Research and Translational Core Center
Efficacy, Safety and Tolerability of Everolimus in Preventing End-Stage Renal Disease in Patients with ADPKD

HALT PKD Progression of PKD (HALT PKD)

Intervention:	Drugs - lisonopril, telmisartan
Sponsor:	University of Pittsburgh Medical Center
Study Phase:	III
Status:	Active; enrollment complete
Age:	15-64
Enrollment goal:	1,018
Description:	To assess the effectiveness of anti-hypertensive drugs telmisartan and lisinopril on PKD progression and its cardiovascular complications in two different levels of kidney function, GFR more than 60 mL/min/1/73m^2 and GFR between 25-60 mL/min/1.73m^2.
Additional Info:	The Data Collection Center is now located at the University of Pittsburgh Medical Center.
Website:	NIH Study Details

Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention:
Sponsor:	The Cleveland Clinic
Study Phase:	I/II
Status:	Active, not recruiting
Age Group:	18-75
Enrollment goal:	30
Description:	This study is a prospective, randomized,open label, pilot clinical trial designed to compare the effects of an agent that has antiproliferative (1,2), antiangiogenesis (3),and tumor-progression blocking capabilities (4), namely, rapamycin (Rapamune®), in the treatment of autosomal-dominant polycystic kidney disease (ADPKD).
Contact:
Website:	NIH Study Details

A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients with ADPKD
(Extension of Trial 156-04-251)

Interventional
Sponsor:	Otsuka Pharmaceutical Co., Ltd.
Study Phase:	III
Status:	Active, not recruiting
Age Group:	23 to 53
Enrollment goal:	150
Description:	To continue ADPKD patients enrolled in Trial 156-04-251 on oral Tolvaptan twice daily.
Website:	NIH Study Details

UAB Recessive PKD Research and Translational Core Center

Observational
Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases
Status:	Active, not recruiting
Age Group:	Up to 35 years
Enrollment goal:	200
Description:	To extend the ARPKD observational study; to provide a mechanism for genetic evaluation of patients with both classic ARPKD and those with unusual phenotypes of recessive PKD; to develop educational tools for physicians and patients regarding the natural history, cause, development and effects of the disease, genetic testing and clinical trials applicable to ARPKD.
Contact:	Lisa M. Guay-Woodford 205-934-7308 or lgw@uab.edu Teresa Chicana, BSN 205-934-7649 or tchacana@uab.edu
Website:	NIH Study Details

Efficacy, Safety and Tolerability of Everolimus in Preventing End-Stage Renal Disease in Patients with ADPKD

Intervention:	Drug - Everolimus
Sponsor:	Novartis
Study Phase:	III
Status:	Active, not recruiting
Age Group:	18-65
Enrollment goal:	400
Description:	This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.
Website:	NIH Study Details