At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
OPC-41061drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
In Brief
A Phase 2 clinical trial evaluating OPC-41061 for Chronic Renal Failure. Completed, enrolled 20 participants across 6 sites.
Detailed Summary
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Failure
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionFeb 2014
Study CompletionAug 2014
TodayJul 2026
First PostedJul 10, 2013
Enrollment StartJul 1, 2013
Primary CompletionFeb 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.0 years ago
Interventions
OPC-41061drug