Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Polycystic Kidney Disease, Autosomal Dominant

In brief

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

Key facts

Study ID

NCT00428948

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1445

Starts

2007-01-01

Expected to finish

2012-01-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Legal adult age and able to give Informed Consent.
• Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.
• Willingness to comply with reproductive precautions, if female.
• Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.
• Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (MRI) at randomization.

You may not qualify if…

• Prior exposure to tolvaptan or other experimental PKD therapies.
• Currently taking medication for purpose of affecting PKD cysts.
• Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
• In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives.
• Patients who are unlikely to adequately comply with study procedures.
• Patients having contraindications to MRI.
• Patients taking medications or having any illnesses likely to affect ADPKD outcomes.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Apex Research of Riverside — Riverside, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Coastal Nephrology Associates Research Center, LLC — Port Charlotte, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Renal Associates of Baton Rough, L.L.C. — Baton Rouge, Louisiana, United States
• John Hopkins School of Medicine — Baltimore, Maryland, United States
• Tufts- New England Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Medical Center — Rochester, Minnesota, United States
• Erie County Medical Center — Buffalo, New York, United States
• Nephrology Associates of Westchester — Hawthorne, New York, United States
• The Rogosin Institute — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina, UNC, Kidney Center — Chapel Hill, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Kidney and Hypertension Center — Cincinnati, Ohio, United States
• University Hospitals of Cleveland/Case — Cleveland, Ohio, United States
• Northwest Renal Clinic, Inc. — Portland, Oregon, United States
• Coastal Clinical Research — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.