Chronic Renal FailurePhase 2NCT01895322
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
A Phase 2 study testing OPC-41061 in people with Chronic Renal Failure, run by Otsuka Pharmaceutical Co., Ltd. at 6 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- 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
- 20 participants
- Where
- 6 sitesJapan
- Study dates
- Jul 2013to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic renal failure
- Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])
- Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload [OR: hypervolemia] that had insufficient effect:
- Addition or increase of diuretics
- Increase in concentration or volume of peritoneal dialysis fluid
- Increase in the number of changes of peritoneal dialysis fluid
- 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
- Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
Who cannot join
- Subjects with any of the following diseases, complications, or symptoms:
- Suspected hypovolemia
- Daily urine volume less than 200 mL
- Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Cardiac function of NYHA class 4
- Subjects with any of the following medical histories:
Show all 22Show fewer
- 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 9.0 g/dL, total bilirubin higher than 3.0 g/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 125 mEq/L, or serum potassium higher than 5.5 mEq/L
- Subjects with any of the following conditions, concomitant diseases, or symptoms:
- defect in diaphragm
- hemorrhagic diathesis due to uremia
- suspected lactic acid metabolic disorder
- suspected peritonitis, peritoneal damage, peritoneal adhesion, or disorders in intraabdominal organs
- Subjects who have undergone peritoneal dialysis for 8 years or longer
- Subjects who are scheduled to undergo hemodialysis or concomitant use of hemodialysis, or renal transplantation
- Subjects who have participated in any other clinical trial or post-marketing clinical studies within 30 days prior to informed consent
- Subjects who have previously received OPC-41061
- Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
- 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
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
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 Peritoneal Dialysis
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.
- Conditions
- Chronic Renal Failure
- Being tested
- OPC-41061
- Keywords
- Tolvaptan, dialysis
- 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
| 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 in Daily Urine Volume From Baseline
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Measured: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
Percent Change in Daily Urine Volume From Baseline
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).
Measured: 100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>
Secondary outcomes (2)
Change in Body Weight From Baseline
Change in body weight from baseline during the repeated-administration period(For five days).
Measured: Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
Percent Change in Body Weight
Percent change in body weight from baseline during the repeated-administration period(For five days).
Measured: 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionAug 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.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoji Imaoka, Mr, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895322
- Sponsor's protocol ID
- 156-12-002
- Other IDs
- JapicCTI-132181
- Status last verified
- Nov 2015
- First submitted
- 4 Jul 2013
- Last updated
- 1 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. 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 Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01895322
- Acronym / sponsor ID
- 156-12-002
- Conditions
- Chronic Renal Failure
- Keywords
- Tolvaptan, dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 1 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with chronic renal failure
- Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])
- Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload [OR: hypervolemia] that had insufficient effect:
- 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
- Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
Key exclusion criteria (22 listed)
- Subjects with any of the following diseases, complications, or symptoms:
- Subjects with any of the following medical histories:
- Subjects with any of the following abnormal laboratory values:
- Hemoglobin lower than 9.0 g/dL, total bilirubin higher than 3.0 g/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 125 mEq/L, or serum potassium higher than 5.5 mEq/L
- Subjects with any of the following conditions, concomitant diseases, or symptoms:
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-41061 | Drug | OPC-41061 |
Primary outcome
Change in Daily Urine Volume From Baseline
Time frame: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Percent Change in Daily Urine Volume From Baseline
Time frame: 100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).
2 secondary outcomes
Change in Body Weight From Baseline
Time frame: Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
Percent Change in Body Weight
Time frame: 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 director
Otsuka Pharmaceutical Co., Ltd.
6 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 6 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 8 inclusion and 22 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 1 Jan 2016). 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 in Daily Urine Volume From Baseline (time frame: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2016.