A clinical trial to evaluate whether a potential new drug is an effective and safe way to preserve kidney function and slow down the progression of kidney disease due to Type 2 Diabetes.
Phase 2
Completed
- Conditions
- Health Condition 1: null- Diabetic Nephropathies
- Registration Number
- CTRI/2011/06/001777
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria
1. Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
2.Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
Note: In India patients greater than or equal to 18 years and less than or equal to 65 years will be enrolled
3.Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 1000 mg/g (greater than or equal to 113 mg/mmol) for greater than 3 months.
Exclusion Criteria
1. Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
2.Subjects with poorly controlled diabetes mellitus, defined as HbA1C 9%.
3. Subjects on combination ACE inhibitor/ARB therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Urine albumin:creatinine ratio (UACR)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method An assessment of the pharmacokinetic parameters of PF-00489791Timepoint: 16 weeks;Estimated glomerular filtration rate at 3, 6, 12 and 16 weeksTimepoint: 16 weeks;Plasma glycosylated hemoglobin (HbA1c).Timepoint: 16 weeks;Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics).Timepoint: 16 weeks;Serum creatinine at 3, 6, 12 and 16 weeksTimepoint: 16 weeks;Serum cystatin C at Weeks 12 and 16Timepoint: 16 weeks;Serum highly sensitive C-reactive protein (hs-CRP) at Weeks 12 and 16.Timepoint: 16 weeks;Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and 16 weeksTimepoint: 16 weeks;Urinary TGFbeta1 at Weeks 3, 6, 12 and 16.Timepoint: 16 weeks;Urine albumin:creatinine ratio at 3, 6 and 16 weeksTimepoint: 16 weeks;Urine protein:creatinine ratio at 3, 6, 12 and 16 weeksTimepoint: 16 weeks