CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 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.

Search/NCT01876381
NCT01876381Phase 2Completed
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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 Hemodialysis or Hemodiafiltration

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jun 12, 2013·Updated Aug 24, 2018

In Brief

A Phase 2 clinical trial evaluating OPC-41061 for Chronic Renal Failure. Completed, enrolled 26 participants across 5 sites.

Detailed Summary

To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase in interval body weights between hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Failure
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 12, 2013
Enrollment StartJun 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.1 years ago

Interventions

OPC-41061drug

The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast