Phase 3
N=1,519
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
Chronic Kidney Disease · Autosomal Dominant Polycystic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02160145 ↗Enrolled (actual)
1,519
Serious AEs
6.6%
Results posted
Aug 2018
Primary outcome: Primary: The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. — -2.339; -3.610 mL/min/1.73 m^2/year — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tolvaptan (OPC-41061) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. |
-2.339; -3.610 | <0.0001 sig |
| SECONDARY Mean Annualized Slope of eGFR Change |
-3.160; -4.170 | <0.0001 sig |
Summary
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)
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02160145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.