Completed

NCT Number: NCT01280721

A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease （ADPKD)

Age range

23 year–53 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion criteria

Patients with eGFR of less than 15 mL/min/1.73 m2
Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study

Treatment and study plan

Tolvaptan

Drug

Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Primary outcomes

Total Kidney Volume

Time frame: Baseline, Month12, Month24, and Month36

Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period.

Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg.

Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.
Renal Function Test (eGFR)

Time frame: Baseline, Month12, Month24, and Month36

Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period.

Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.
Renal Function Test (Cys-C)

Time frame: Baseline, Month 12, Month 24, and Month 36

Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Jan 21, 2011
Registry last updated: Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.