None listed
Conditions
Interventions
Subjects will be randomized to one of
2 treatment arms (PF-04634817 200 mg QD or placebo QD) in a 3:1 ratio.
Subjects will complete the 12 weeks
of dosing.
PF-04634817 and placebo will b
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects ≥ 18 years. 2. Female subjects who are not of non-child bearing potential (This will be confirmed medically ) 3. Clinical diagnosis of type 2 diabetes together with stages 3a or 3b CKD 4. Stable background therapy of RAAS inhibition 5. Resting BP ≤165/105 mm Hg.
Exclusion criteria
Exclusion criteria: 1. Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD. 2. Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy. 3. Subjects who have had a kidney transplant, or who require renal replacement therapy. 4. Subjects who have a history of proteinuria 5. Subjects who have serum albumin 450 msec, a QRS >120 msec, or any clinically significant ischemic 14. Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol. 15. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years. 16. Blood donation in the previous 4 weeks, or stated intention to donate blood. 17. Participation in other studies within the previous 60 days. 18. Pregnant females; breastfeeding females; females of childbearing potential; males not using highly effective contraception .
Countries
Australia, Brazil, Canada, Germany, India, Italy, Korea South, Poland, Romania, Spain, United States
Outcome results
None listed