Renal Insufficiency, ChronicPhase 2NCT02480751
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
A Phase 2 study testing Beraprost in people with Renal Insufficiency, Chronic, run by Toray Industries, Inc.
Trial summary
The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Beraprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
- The patient with progressive CRF
Who cannot join
- The patient with secondary glomerular disease
- The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis
About this study
The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Beraprost, Placebo
- Keywords
- Chronic Renal Failure, Prostaglandin, Prostacyclin, Glomerular Disease; Nephrosclerosis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Nephrosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeraprostDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1: Exprimental (TRK-100STP) | Experimental | high dose Receives: Drug: Beraprost |
| 2: Exprimental (TRK-100STP) | Experimental | low dose Receives: Drug: Beraprost |
| 3: Placebo Comparator | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time
Measured: 50 weeks (Run-in 22weeks, Treatment 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startOct 2005
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480751
- Sponsor's protocol ID
- 100CRS01/533-CL-00
- Status last verified
- Jun 2015
- First submitted
- 21 Jun 2015
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koyama A, Fujita T, Gejyo F, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial. BMC Nephrol. 2015 Oct 16;16:165. doi: 10.1186/s12882-015-0130-5.
PubMed 26475266
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
- ClinicalTrials.gov ID
- NCT02480751
- Acronym / sponsor ID
- 100CRS01/533-CL-00
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic Renal Failure, Prostaglandin, Prostacyclin, Glomerular Disease; Nephrosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Exprimental (TRK-100STP) | Experimental | Drug: Beraprosthigh dose |
| 2: Exprimental (TRK-100STP) | Experimental | Drug: Beraprostlow dose |
| 3: Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
- The patient with progressive CRF
Key exclusion criteria (2 listed)
- The patient with secondary glomerular disease
- The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis
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 |
|---|---|---|
| Beraprost | Drug | 1: Exprimental (TRK-100STP), 2: Exprimental (TRK-100STP) |
| Placebo | Drug | 3: Placebo Comparator |
Primary outcome
Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time
Time frame: 50 weeks (Run-in 22weeks, Treatment 28 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Derived from this study: PubMed 26475266Koyama A, Fujita T, Gejyo F, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial. BMC Nephrol. 2015 Oct 16;16:165. doi: 10.1186/s12882-015-0130-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beraprost in people with Renal Insufficiency, Chronic, run by Toray Industries, Inc.
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 2 inclusion and 2 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 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time (time frame: 50 weeks (Run-in 22weeks, Treatment 28 weeks)). 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 NCT02480751, which also lists 1 linked publication.
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 29 Jun 2015.