Overview
A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy
Status:
Completed
Completed
Trial end date:
2014-09-01
2014-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:- Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based
on an eGFR of 20-75 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9
mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
- 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.
Exclusion Criteria:
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD),
severe peripheral vascular disease (PVD) or obstructive uropathy.