- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01572610
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
February 28, 2017 updated by: Kyowa Kirin Co., Ltd.
A Phase 2 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
An exploratory study to investigate the effects of RTA 402 on glomerular filtration rate in CKD patients with type 2 diabetes mellitus.
To evaluate the safety of RTA 402.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ibaraki
-
Koga city, Ibaraki, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Patients for whom Inulead® injection is contraindicated etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: RTA 402
|
once a day, oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: glomerular filtration rate measured by inulin clearance
Time Frame: Up to 16 weeks
|
Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated.
|
Up to 16 weeks
|
Adverse Event collection and assessment
Time Frame: Up to 16 weeks
|
Adverse Event collection
|
Up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2012
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ACTUAL)
November 1, 2013
Study Registration Dates
First Submitted
April 4, 2012
First Submitted That Met QC Criteria
April 5, 2012
First Posted (ESTIMATE)
April 6, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 3, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTA 402-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on RTA 402
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Reata, a wholly owned subsidiary of BiogenWithdrawn
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Reata, a wholly owned subsidiary of BiogenTerminatedLiver DiseaseUnited States
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Kyowa Kirin Co., Ltd.TerminatedType 2 Diabetes | Chronic Kidney DiseaseJapan
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M.D. Anderson Cancer CenterReata Pharmaceuticals, Inc.CompletedSolid Tumors | Lymphoid MalignanciesUnited States
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Kyowa Kirin Co., Ltd.CompletedType 2 Diabetes | Chronic Kidney DiseaseJapan
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Reata, a wholly owned subsidiary of BiogenTerminatedChronic Kidney Diseases | Autosomal Dominant Polycystic Kidney | Alport SyndromeUnited States, France, Australia, Japan, Spain, Puerto Rico
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Reata, a wholly owned subsidiary of BiogenCompletedDiabetic NephropathyUnited States
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Kyowa Kirin Co., Ltd.TerminatedDiabetic Kidney DiseaseJapan
-
Reata, a wholly owned subsidiary of BiogenTerminatedDiabetes Mellitus, Type 2 | Renal Insufficiency, Chronic