Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02160145 ↗Enrolled (actual)
1,519
Serious AEs
6.6%
Results posted
Aug 2018
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
619citations · ~69 / year
Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease.
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)
Linked Publications (5)
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Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease.
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Clinical Pattern of Tolvaptan-Associated Liver Injury in Trial Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD): An Analysis of Pivotal Clinical Trials.
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Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model.
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Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies.
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Interventions for preventing the progression of autosomal dominant polycystic kidney disease.
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 |
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) and the linked publication. 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. Informational only — not medical advice.