Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease

In brief

The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)

Key facts

Study ID

NCT02160145

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1370

Starts

2014-05-01

Expected to finish

2017-04-18

Last updated by the study team

2018-08-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66)
• Tolvaptan naïve
• Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history

You may not qualify if…

• Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Investigational medicinal product (IMP)
• Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP
• Need for chronic diuretic use
• Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
• Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
• Contraindications to required trial assessments
• Medical history or medical findings inconsistent with safety or compliance with trial assessments

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Hudson, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Meridian, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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