Chronic Renal FailurePhase 2/3NCT01090037
TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
A Phase 2/3 study testing TRK-100STP high dose and TRK-100STP low dose in people with Chronic Renal Failure and Glomerular Disease, run by Toray Industries, Inc at 7 sites in 7 countries.
Trial summary
In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease: To confirm the superiority of TRK-100STP over placebo To determine the recommended therapeutic dose in the 2 doses of TRK-100STP To assess the safety of TRK-100STP Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Renal Failure, Glomerular Disease, Nephrosclerosis
- What is being tested?
- TRK-100STP high dose and TRK-100STP low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 892 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Mar 2010to Jan 2015
- Phase
- Phase 2/3
- 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 18 to 75 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
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease:
- To confirm the superiority of TRK-100STP over placebo
- To determine the recommended therapeutic dose in the 2 doses of TRK-100STP
- To assess the safety of TRK-100STP
- Conditions
- Chronic Renal Failure, Glomerular Disease, Nephrosclerosis
- Being tested
- TRK-100STP high dose, TRK-100STP low dose, Placebo
- Keywords
- ESRD, Chronic Renal Failure, Prostaglandin, Prostacyclin, Asian Multinational Study
- Medical subject headings
- Kidney Failure, Chronic, Nephrosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-100STP high doseDrug
TRK-100STP low doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TRK-100STP | Experimental | Not described Receives: Drug: TRK-100STP high dose; Drug: TRK-100STP low dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal composite endpoints [Time to first occurrence of one of the following events:]
(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value
(ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher
Measured: 2-4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 892 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
- NCT01090037
- Sponsor's protocol ID
- 100CRS02/533-CL-003
- Status last verified
- Feb 2015
- First submitted
- 8 Mar 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730Nakamoto H, Fujita T, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design. BMC Nephrol. 2014 Sep 19;15:153. doi: 10.1186/1471-2369-15-153.
PubMed 25233856
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
- ClinicalTrials.gov ID
- NCT01090037
- Acronym / sponsor ID
- 100CRS02/533-CL-003
- Conditions
- Chronic Renal Failure, Glomerular Disease, Nephrosclerosis
- Keywords
- ESRD, Chronic Renal Failure, Prostaglandin, Prostacyclin, Asian Multinational Study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Mar 2010 (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.
In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease:
- To confirm the superiority of TRK-100STP over placebo
- To determine the recommended therapeutic dose in the 2 doses of TRK-100STP
- To assess the safety of TRK-100STP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRK-100STP | Experimental | Drug: TRK-100STP high dose, Drug: TRK-100STP low dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 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 |
|---|---|---|
| TRK-100STP high dose | Drug | TRK-100STP |
| TRK-100STP low dose | Drug | TRK-100STP |
| Placebo | Drug | Placebo |
Primary outcome
Renal composite endpoints [Time to first occurrence of one of the following events:]
Time frame: 2-4 year
(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value (ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher
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 4 Feb 2015.
- Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
- Derived from this study: PubMed 25233856Nakamoto H, Fujita T, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design. BMC Nephrol. 2014 Sep 19;15:153. doi: 10.1186/1471-2369-15-153.
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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.
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TRK-100STP high dose and TRK-100STP low dose in people with Chronic Renal Failure and Glomerular Disease, run by Toray Industries, Inc at 7 sites in 7 countries.
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 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Hong Kong, Japan, Malaysia, South Korea and 2 more countries. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Renal composite endpoints [Time to first occurrence of one of the following events:] (time frame: 2-4 year). 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 NCT01090037, which also lists 2 linked publications.
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 4 Feb 2015.