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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
226
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
Time frame: Baseline and Week 12
Change From Baseline in UACR at Weeks 4, 8 and 16
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
Time frame: Baseline, Weeks 4, 8 and 16
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16
The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16
eGFR was calculated using the MDRD equation and normalized to 1.73 m\^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR
Time frame: Baseline, Week 1, 4, 8, 12 and 16
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16
Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m\^2 body surface area.
Time frame: Baseline, Week 12, and Week 16
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16
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Medical Investigations, Inc.
Little Rock, Arkansas, United States
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
...and 132 more locations
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.
Time frame: Baseline, Week 1, 4, 8, 12 and 16
Change From Baseline in Serum Cystatin C at Weeks 12 and 16
Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.
Time frame: Baseline, Week 12, and Week 16
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12
Time frame: 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12