Chronic Renal FailurePhase 2NCT01876381

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

A Phase 2 study testing OPC-41061 in people with Chronic Renal Failure, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Chronic Renal Failure
What is being tested?: OPC-41061
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 5 sitesJapan
Study dates: Jun 2013to Feb 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration three times a week
Subjects between the ages of 20 and 80, inclusive (at time of informed consent)
Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after the final trial drug administration
Patients who are capable of providing written informed consent themselves before any trial-related procedures are performed

Who cannot join

Subjects with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
Subject with daily urine volume less than 500 mL
Subject with Cardiac function of NYHA class 4
Subjects with serious ischemic heart disease, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Subjects with serious arrhythmia, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Subjects who are concomitantly undergoing peritoneal dialysis

Show all 17Show fewer

Subjects with ascites due to cirrhosis or cancer, requring medical treatments
Subjects with any of the following medical histories:
History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent
History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
Subjects with any of the following abnormal laboratory values:
Hemoglobin lower than 8.0 g/dL, total bilirubin higher than 3.0 mg/dL, ALT (GPT) or AST (GOT) 2 times the upper limit of the reference range of the trial site, serum sodium higher than the upper limit of the reference range of the trial site, serum sodium lower than 125mEq/L
Subjects with serum potassium higher than 6.0mEq/L and abnormal findings inappropriate for inclusion in the trial are observed by 12-lead ECG
Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
Subjects who have participated in any other clinical trial or post-marketing clinical studies within 4 weeks prior to informed consent
Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period
Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Study site
Chube Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Tohoku Region

Other trials in Japan

About this study

Conditions: Chronic Renal Failure
Being tested: OPC-41061
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01876381
Study group	Role	What they receive
OPC-41061	Experimental	Not described Receives: Drug: OPC-41061

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Daily Urine Volume
The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation [SD], minimum, median, maximum [same for following parameters]).
Measured: Baseline and Day 14 (Intermittent Administration Period)

Secondary outcomes (1)

Change From Baseline in Total Fluid Removal Per Week by Dialysis
The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.
Measured: Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Feb 2014

First posted12 Jun 2013 (estimated)
Study startJun 2013
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01876381
Sponsor's protocol ID: 156-12-007
Other IDs: JapicCTI-132147
Status last verified: Nov 2017
First submitted: 9 Jun 2013
Last updated: 24 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
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A Natural History Study of Metabolic Sizing in Health and Disease
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Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)

All Chronic Renal Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01876381
Acronym / sponsor ID: 156-12-007
Conditions: Chronic Renal Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 12 Jun 2013 (estimated)
Results: Posted 24 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OPC-41061	Experimental	Drug: OPC-41061

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration three times a week
Subjects between the ages of 20 and 80, inclusive (at time of informed consent)
Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after the final trial drug administration
Patients who are capable of providing written informed consent themselves before any trial-related procedures are performed

Key exclusion criteria (17 listed)

Subjects with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
Subject with daily urine volume less than 500 mL
Subject with Cardiac function of NYHA class 4
Subjects with serious ischemic heart disease, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Subjects with serious arrhythmia, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-41061The 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	Drug	OPC-41061

Primary outcome

Change From Baseline in Daily Urine Volume
Time frame: Baseline and Day 14 (Intermittent Administration Period)
The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation [SD], minimum, median, maximum [same for following parameters]).

1 secondary outcome

Change From Baseline in Total Fluid Removal Per Week by Dialysis
Time frame: Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)

Results and safety

Results posted to the registry on 24 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-41061	23	16

Primary outcome: Change From Baseline in Daily Urine Volume

Time frame: Baseline and Day 14 (Intermittent Administration Period). Mean (Standard Deviation). Unit: ml

Measure	OPC-41061 n = 16
Value	481.0 (427.1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the start date of IMP administration to date of the final examination (up to Intermittent Administration Period Day15). Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-41061	0 of 23 (0%)	13 of 23 (56.5%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Renal Failure

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kyoji Imaoka, Mr study chair

Otsuka Pharmaceutical Co., Ltd.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPC-41061 in people with Chronic Renal Failure, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Daily Urine Volume (time frame: Baseline and Day 14 (Intermittent Administration Period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01876381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.