Chronic Kidney DiseasePhase 2NCT01574365
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing RTA 402 in people with Chronic Kidney Disease and Type 2 Diabetes, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- What is being tested?
- RTA 402
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2012to Nov 2013
- 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
- CKD patients with type 2 diabetes mellitus
- Patients whose eGFR levels are eligible for this study
- Patients being treated with stable dose of ACE inhibitors and/or ARB etc.
Who cannot join
- Patients with Type 1 diabetes
- Patients with known non-diabetic renal disease
- Patients with a history of renal transplantation
- Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg
- Patients with HbA1C > 10%
- Patients with cardiovascular disease specified in the study protocol etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
Read the detailed description
To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus.
To evaluate the safety and tolerability of RTA 402.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- RTA 402
- Keywords
- CKD patients with type 2 diabetes
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTA 402Drug
| Study group | Role | What they receive |
|---|---|---|
| RTA402 | Experimental | Not described Receives: Drug: RTA 402 |
| RTA402 Low | Experimental | Not described Receives: Drug: RTA 402 |
| RTA402 Medium-low | Experimental | Not described Receives: Drug: RTA 402 |
| RTA402 Medium-high | Experimental | Not described Receives: Drug: RTA 402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy:Changes in eGFR
Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
Measured: Up to 16 weeks
Adverse event collection and assessment
Adverse Event collection and assessment will be done for all treated subjects.
Measured: Up to 16 weeks
Secondary outcomes (1)
Profile of Pharmacokinetics
Relationship between the study drug dose and the trough concentration of study drug
Measured: Baseline, week 4, 8 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574365
- Sponsor's protocol ID
- RTA 402-003
- Status last verified
- Feb 2017
- First submitted
- 4 Apr 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01574365
- Acronym / sponsor ID
- RTA 402-003
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Keywords
- CKD patients with type 2 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Apr 2012 (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.
A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
Detailed description
To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus.
To evaluate the safety and tolerability of RTA 402.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RTA402 | Experimental | Drug: RTA 402 |
| RTA402 Low | Experimental | Drug: RTA 402 |
| RTA402 Medium-low | Experimental | Drug: RTA 402 |
| RTA402 Medium-high | Experimental | Drug: RTA 402 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD patients with type 2 diabetes mellitus
- Patients whose eGFR levels are eligible for this study
- Patients being treated with stable dose of ACE inhibitors and/or ARB etc.
Key exclusion criteria (6 listed)
- Patients with Type 1 diabetes
- Patients with known non-diabetic renal disease
- Patients with a history of renal transplantation
- Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg
- Patients with HbA1C > 10%
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 |
|---|---|---|
| RTA 402 | Drug | RTA402, RTA402 Low, RTA402 Medium-high, RTA402 Medium-low |
Primary outcome
Efficacy:Changes in eGFR
Time frame: Up to 16 weeks
Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.
Adverse event collection and assessment
Time frame: Up to 16 weeks
Adverse Event collection and assessment will be done for all treated subjects.
1 secondary outcome
Profile of Pharmacokinetics
Time frame: Baseline, week 4, 8 and 12.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTA 402 in people with Chronic Kidney Disease and Type 2 Diabetes, run by Kyowa Kirin Co., Ltd. at 1 site 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early. Results are not available in the source record.
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?
Efficacy:Changes in eGFR (time frame: Up to 16 weeks). 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 3 Mar 2017.