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

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Brief Title

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

Official Title

A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Brief 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)
    

Detailed Description

      The protocol will extend the understanding of the efficacy and safety of tolvaptan treatment
      in ADPKD patients with late stage 2 to early stage 4 CKD (chronic kidney disease).

      This trial will compare the efficacy of tolvaptan treatment in reducing the annualized change
      in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment
      follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial
      run-in period. The change in eGFR, calculated by the Chronic Kidney Disease-Epidemiology
      (CKD-EPI) formula, will provide kidney function data that are complementary to the data
      demonstrating the benefits previously observed primarily in ADPKD subjects with earlier
      stages of disease.

      Also, it will compare the efficacy of tolvaptan treatment in reducing the decline of
      annualized eGFR slope, as compared with placebo, in this type of subjects. Finally, it will
      compare the overall and hepatic safety profile of tolvaptan with placebo and to compare
      incidence of ADPKD complications (outcomes) during the trial
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.

Secondary Outcome

 Mean Annualized Slope of eGFR Change

Condition

Chronic Kidney Disease

Intervention

Tolvaptan (OPC-41061)

Study Arms / Comparison Groups

 Tolvaptan
Description:  Tolvaptan (OPC-41061)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1370

Start Date

May 2014

Completion Date

April 18, 2017

Primary Completion Date

April 18, 2017

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT02160145

Organization ID

156-13-210


Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.


Study Sponsor

, , 


Verification Date

July 2018