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Pfizer B1261007

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Mutli-Center Study to Evaluate the Efficacy and Safety of Once-Daily Administration of a Chemokine CCR2/5 Receptor Antagonist (PF-04634817) in Adults with Type 2 Diabetes and Overt Nephropathy

Objective

PF-04634817 is a chemokine CCR2/5 receptor antagonist that is being developed for the treatment of diabetic nephropathy

IRB Protocol Number
12-1419

All Other Trials

  • Diabetes
  • Endocrine (Hormones)
Contact
Brad Wine at 720-848-5596
or bradley.wine@ucdenver.edu
Eligibility and Other Participant Information

Inclusion Criteria

1. Male or female subjects ³18 years.

2. Female subjects who are not of non-child bearing potential (ie, meet at least one of the following criteria):
-Have medically confirmed ovarian failure
-Are medically confirmed to be postmenopausal
-Have undergone hysterectomy or bilateral oophorectomy

3. Clinical diagnosis of type 2 diabetes together with stages 3a or 3b CKD.

4. Evidence of persistent, overt albuminuria.

5. Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

6. Resting BP 165/105 mm Hg. Subjects with resting BP >135/85 but £165/105 must be being treated with at least one antihypertensive medication in addition to ACEi or ARB and have been on a stable dose(s) for at least 30 days.

 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 >8.5 g/day.

5. Subjects who have serum albumin <2.0 g/dL (<20 g/L).

6. Subjects with poorly controlled diabetes mellitus, defined as HbA1C >10.5%.

7. Subjects on direct renin inhibitor therapy.

8. Known history of human immunodeficiency (HIV).

9. History of congestive heart failure (NYHA class III or IV) or unstable angina, or a history of myocardial infarction, stroke or transient ischemic attack in the previous 6 months.

10. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin); no cancer recurrence in the previous 5 years.

Location

  • University of Colorado Hospital (UCH)
    12605 E. 16th Ave.
    Aurora, CO 80045