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 |
---|---|
Conditions: | Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Diabetes |
Therapuetic Areas: | Endocrinology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2012 |
End Date: | September 2014 |
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-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
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.
with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a
surrogate for improved glomerular filtration.
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.
We found this trial at
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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