This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL784 when given daily to patients with albuminuria due to diabetic nephropathy. XL784 is a small molecule reno-protective metalloproteinase inhibitor, inhibiting both ADAMs (including ADAM10, a target of significant interest because of its important role in blood vessel formation and cell proliferation, and ADAM17/TACE, activation of which has been associated with renal deterioration) and MMPs (including MMP-2 and MMP-9). XL784 was specifically optimized to be MMP-1 sparing, which may be clinically significant because inhibition of MMP-1 has been hypothesized to be associated with musculoskeletal toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
Parkway Medical Center
Birmingham, Alabama, United States
Winston Technology, Inc.
Haleyville, Alabama, United States
Redpoint Research
Phoenix, Arizona, United States
International Clinical Research Network, Inc.
Chula Vista, California, United States
Scripps Clinic, Torrey Pines, Division of Nephrology
La Jolla, California, United States
Reduction in albumin excretion relative to creatinine
Time frame: 27 weeks
Safety and tolerability
Time frame: 27 weeks
Pharmacokinetics and renal elimination
Time frame: 27 weeks
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National Research Institute
Los Angeles, California, United States
West Los Angeles VA Medical Center
Los Angeles, California, United States
UCLA Medical Center, Center for the Health Sciences
Los Angeles, California, United States
Arroyo Research Inc.
Pasadena, California, United States
Western Nephrology and Metabolic Bone Disease, PC
Lakewood, Colorado, United States
...and 35 more locations