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]

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial

Official 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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280721
• Other study ID #: 156-10-003
• Secondary ID: JapicCTI-101362
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2018
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 53 Years

Eligibility

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

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Kidney Volume	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.	Baseline, Month12, Month24, and Month36
Primary	Renal Function Test (eGFR)	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.	Baseline, Month12, Month24, and Month36
Primary	Renal Function Test (Cys-C)	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.	Baseline, Month 12, Month 24, and Month 36