Chronic Renal FailurePhase 2NCT02331680
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (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 4 sites in Japan.
Trial summary
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 4 sitesJapan
- Study dates
- Dec 2014to May 2016
- 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
- Chronic renal failure requiring hemodialysis or hemodiafiltration 3 times a week
- Daily urine volume of ≥ 500 mL/day
- Male or female patients age 20 to 80 years, inclusive
- Use of one of the specified contraceptive methods until 4 weeks after final IMP administration
- Capable of providing their own written informed consent prior to any trial-related procedures being performed
Who cannot join
- Patients with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Patients with NYHA class IV heart failure
- Patients with impaired hepatic function(chronic hepatitis, drug-induced liver injury)
- Patients with serious ischemic heart disease who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- Patients with serious arrhythmia who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- Patients with serious secondary hyperparathyroidism(intact parathyroid hormone > 500 pg/mL)
Show all 14Show fewer
- Patients who are concomitantly undergoing peritoneal dialysis
- Patients with a history of cerebrovascular disease or coronary artery disease within 4 weeks prior to informed consent, a history of hypersensitivity to any ingredient of tolvaptan or benzazepine derivatives such as mozavaptan hydrochloride or a history of impaired hepatic function(chronic hepatitis, drug-induced liver injury)
- Patients with any of the following abnormal laboratory values: hemoglobin < 8.0 g/dL, total bilirubin > 3.0 mg/dL, ALT (GPT) or AST (GOT) > 2 times the upper limit of the reference range, serum sodium > upper limit of the reference range, serum sodium < 125 mEq/L, or serum potassium > 6.0 mEq/L
- Patients who are unable to sense thirst or who have difficulty with fluid intake
- Patients who have received OPC-41061 in history.
- Participation in any other clinical trial or post-marketing clinical study within 4 weeks prior to informed consent for the present trial
- Female patients who are pregnant, possibly pregnant, or nursing
- Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Kanto, Region
Study site
Kinki, Region
Study site
Kyushu, Region
Study site
Tōhoku, Region
About this study
Official title: A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.
- Conditions
- Chronic Renal Failure
- Being tested
- OPC-41061, Placebo
- Keywords
- Undergoing Hemodialysis, Undergoing Hemodiafiltration
- 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
Also called Tolvaptan
OPC-41061Drug
Also called Tolvaptan
PlaceboDrug
Also called Blank Tablet
| Study group | Role | What they receive |
|---|---|---|
| OPC-41061 15mg/day | Experimental | Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 24 week. Receives: Drug: OPC-41061 |
| OPC-41061 30mg/day | Experimental | Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 1 week and then OPC-41061 30 mg/day for 23 weeks Receives: Drug: OPC-41061 |
| Placebo | Placebo comparator | Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. Placebo will be administered for 24 week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Daily Urine Volume
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Measured: Baseline，End of the treatment
Secondary outcomes (1)
Change in Total Volume of Fluid Removed by Dialysis Per Week
Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.
Measured: Baseline，End of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionMay 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroaki Ono, Mr., Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331680
- Sponsor's protocol ID
- 156-13-003
- Other IDs
- JapicCTI-142756
- Status last verified
- Oct 2019
- First submitted
- 23 Dec 2014
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
- ClinicalTrials.gov ID
- NCT02331680
- Acronym / sponsor ID
- 156-13-003
- Conditions
- Chronic Renal Failure
- Keywords
- Undergoing Hemodialysis, Undergoing Hemodiafiltration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPC-41061 15mg/day | Experimental | Drug: OPC-41061Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 24 week. |
| OPC-41061 30mg/day | Experimental | Drug: OPC-41061Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 1 week and then OPC-41061 30 mg/day for 23 weeks |
| Placebo | Placebo comparator | Drug: PlaceboWill be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. Placebo will be administered for 24 week. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic renal failure requiring hemodialysis or hemodiafiltration 3 times a week
- Daily urine volume of ≥ 500 mL/day
- Male or female patients age 20 to 80 years, inclusive
- Use of one of the specified contraceptive methods until 4 weeks after final IMP administration
- Capable of providing their own written informed consent prior to any trial-related procedures being performed
Key exclusion criteria (14 listed)
- Patients with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Patients with NYHA class IV heart failure
- Patients with impaired hepatic function(chronic hepatitis, drug-induced liver injury)
- Patients with serious ischemic heart disease who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- Patients 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-41061Also: Tolvaptan | Drug | OPC-41061 15mg/day |
| OPC-41061Also: Tolvaptan | Drug | OPC-41061 30mg/day |
| PlaceboAlso: Blank Tablet | Drug | Placebo |
Primary outcome
Change From Baseline in Daily Urine Volume
Time frame: Baseline，End of the treatment
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
1 secondary outcome
Change in Total Volume of Fluid Removed by Dialysis Per Week
Time frame: Baseline，End of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- 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.
Hiroaki Ono, Mr. study director
Otsuka Pharmaceutical Co., Ltd.
4 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 4 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 14 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 22 Oct 2019). 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，End of the treatment). 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 22 Oct 2019.