A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes
This study has been terminated.
(IDMC recommendation for safety concerns)
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
First received: December 22, 2011
Last updated: November 1, 2012
Last verified: November 2012
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints.
Chronic Kidney Disease
Type 2 Diabetes
Drug: 20 mg bardoxolone methyl
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Pharmacodynamic Study of Measured Glomerular Filtration Rate Assessed by Tc99m-DTPA in Patients With Chronic Kidney Disease and Type 2 Diabetes
Primary Outcome Measures:
- Measured GFR assessed by plasma clearance of Tc99m-DTPA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Measured GFR assessed by plasma clearance of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20
Secondary Outcome Measures:
- Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20
- Circulating endothelial cell assessments [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Circulating endothelial cell assessments at Baseline mGFR assessment 1 and at Weeks 8 and 20
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Oral, once daily
Experimental: Bardoxolone methyl
Drug: 20 mg bardoxolone methyl
20 mg, oral, once daily
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Screening eGFR ≥ 30.0 and < 60.0 mL/min/1.73 m2;
- A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age (if diabetes developed at a younger age, a fasting C-peptide level must be ≥ 0.1 ng/mL to confirm type 2 diabetes);
- Male or female patients at least 18 years of age;
- Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 6 weeks prior to Screening Visit and during screening. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to Screening Visit A and during screening (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB, or taking an ACE inhibitor and/or ARB at levels below the goal dose set by K/DOQI guidelines (See Appendix 3) should have a documented medical contraindication (e.g., hyperkalemia, dry cough, angioedema), which the investigator must discuss with the appropriate medical monitor;
- Albumin/creatinine ratio (ACR) < 300 mg/g;
- Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mmHg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within the described range;
- Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential, [see Section 9.7]) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested;
- Willing and able to cooperate with all aspects of the protocol;
- Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records that describe events captured in the endpoints.
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No publications provided
||Reata Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 22, 2011
||November 1, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 15, 2014
Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Endocrine System Diseases