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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT01712061

Run by

Pfizer

People needed

226

Starts

2012-12-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• North America Research Institute — Azusa, California, United States
• California Institute of Renal Research — Chula Vista, California, United States
• California Kidney Specialists — Covina, California, United States
• Diabetes/Lipid Management and Research Center — Huntington Beach, California, United States
• Tower Nephrology Medical Group — Los Angeles, California, United States
• Richard S. Cherlin, MD — Los Gatos, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Central Coast Nephrology — Salinas, California, United States
• California Kidney Specialists — San Dimas, California, United States
• University of Colorado Denver/University of Colorado Hospital — Aurora, Colorado, United States
• Gulf Coast Endocrine and Diabetes Center — Clearwater, Florida, United States
• Continental Research Corp. — Doral, Florida, United States
• Premier Research Associate, Inc. — Hialeah, Florida, United States
• Prestige Clinical Research Center — Miami, Florida, United States
• Elite Clinical Research — Miami, Florida, United States
• Nephrology Associates of South Miami — Miami, Florida, United States
• Tellus Clinical Research, Inc. — Miami, Florida, United States
• Ocean Blue Medical Research Center, Inc — Miami Springs, Florida, United States
• Diabetes Care Center — New Port Richey, Florida, United States
• Gulf Coast Kidney Center — New Port Richey, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Pines Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Christie Clinic, LLC — Champaign, Illinois, United States
• Medical Investigations, Inc. — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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