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.

 
 
     

 

Active, Not Recruiting

Drug Pipeline

 

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

 

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.
Websites: NIH Study Details

 

Sirolimus (Rapamune) for ADPKD

 

Intervention:

Drug - Rapamycin

Sponsor:

The University of Zurich

Study Phase:

III
Status: Active, enrollment complete
Age Group: 18-40

Enrollment goal:

100

Description:

To investigate whether a low dose of sirolimus retards cyst growth and slows renal functional deterioration in patients with ADPKD.
Contact: Andreas Serra, MD  41 44 255 33 84  or  andreas.serra@usz.ch
Website: NIH Study Details

 

Pilot Study of Rapamycin as Treatment for ADPKD

 

Intervention:

Drug - Rapamycin

Sponsor:

The Cleveland Clinic

Study Phase:

I & II
Status: Active, not recruiting
Age Group: 18-75

Enrollment goal:

30

Description:

To compare the effects of an anti-proliferative, anti-angiogenesis and tumor-progression-blocking agent on disease progression in ADPKD.  Due to the intensive and frequent testing schedule, enrollment is limited to local patients only.
Contact: Susan Wirth  216-444-0124  or  wirths@ccf.org
Website: NIH Study Details

 

Somatostatin in Polycystic Kidney: A Long-term Three Year Follow-up Study

 

Intervention:

Drug - Long-acting somatostatin

Sponsor:

Mario Negri Institute for Pharmacological Research

Study Phase:

III
Status: Active, not recruiting
Age Group: 18-75

Enrollment goal:

78

Description:

To compare the effects on disease progression of a three year treatment regimen using long-acting somatostatin or placebo in patients with ADPKD and normal renal function or mild to moderate renal insufficiency.
Contact: Norberto Perico, MD  0039 035-45351  or  perico@marionegri.it
Website: NIH Study Details

 

Octreotide in Severe Polycystic Liver Disease

 

Intervention:

Drug - Octreotide (long-acting somatostatin)

Sponsor:

Mayo Clinic; Novartis

Study Phase:

II & III
Status: Active, not recruiting
Age Group: 18-80

Enrollment goal:

42

Description:

To evaluate the effect of Octreotide LAR on liver volumes of patients with severe polycystic liver disease who are not candidates for or decline surgical treatments such as liver cyst fenestration or liver transplantation.
Contact: Marie Hogan, M.D., Ph.D.  507-538-9851
Linda Page  507-538-9851
Website: NIH Study Details

 

Open Label Extension of LOCKCYST Trial

 

Intervention:

Drug - Lanreotide

Sponsor:

Radboud University/IPsen
Study Phase: II & III
Status: Unknown
Age Group: 18-88

Enrollment goal:

54

Description:

Continuation of LOCKCYST Trial.
Website: NIH Study Details

 

High Water Intake to Slow Progression of PKD

 

Intervention:

Water

Sponsor:

New York University School of Medicine
Study Phase: II
Status: Active, not recruiting
Age Group: 18-65

Enrollment goal:

20

Description:

To evaluate the changes in urine composition in PKD patients versus healthy individuals with high water intake by monitoring urinary biomarkers.
Contact: Irina Barash, MD  212-263-5851  or  irina.barash@nyumc.org
Website: NIH Study Details

 

Somatostatin in Patients with ADPKD and Moderate to Severe Renal Insufficiency (ALADIN 2)

 

Intervention:

Octreotide-LAR

Sponsor:

Mario Negri Institute for Pharmacological Research
Study Phase: III
Status: Active, not recruiting
Age Group: 18-75

Enrollment goal:

80

Description:

To assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR)
compared to placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe
renal insufficiency.
Contact: Norberto Perico, Mario Negri Institute for Pharmacological Research
Website: NIH Study Details

 

 
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