Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Albuminuria, Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT00312780

Run by

Symphony Evolution, Inc.

People needed

125

Starts

2006-03-01

Expected to finish

2007-12-01

Last updated by the study team

2010-02-23

Who can join

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

You may qualify if…

• Type 1 or Type 2 diabetes mellitus with albuminuria, observed within 3 months of screening
• Prior to randomization, subject has a glomerular filtration rate (GFR) >/= 40 mL/min
• Prior to randomization, the subject has albuminuria defined as ACR >/= 500 mg/g
• Stable seated blood pressure at the screening visit and prior to randomization
• Subject has been on a stable dose and schedule of an angiotension converting enzyme (ACE) inhibitor and/or an angiotension receptor blocker (ARB) for at least 3 months before first dose of study drug
• If on antidiabetic medication, subject has been on a stable dose and schedule for at least 3 months prior to first dose of study drug
• Sexually active subjects must use an accepted method of contraception during the course of the study and for 3 months after
• Signed informed consent

You may not qualify if…

• Subject has participated in an investigational study and received an investigational drug within 30 days of the first dose of XL784
• Hemoglobin A1c (HbA1c) value of >10% at screening
• Subject has had either organ transplantation or is currently on immunosuppressive therapy
• Non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days of urine screening assessments
• Current diagnosis of one or more of the following conditions: 1) infection requiring parenteral antibiotics, 2) urinary tract infection, 3) hepatic dysfunction or disease, 4) symptomatic congestive heart failure, 5) unstable angina pectoris, 5) serious cardiac arrhythmia
• Clinically evident diabetic gastroparesis or motility disturbance
• Proteinuria not due to diabetic nephropathy
• Diltiazem or verapamil
• Ongoing condition where treatment with NSAIDs is anticipated (aspirin </= 325 mg/day is allowed)
• Recent history of drug or alcohol abuse
• Pregnant or breastfeeding female subjects
• Known HIV and/or receiving anti-retroviral therapy
• Known allergy or hypersensitivity to any component of XL784 formulation

Where it is running

• 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
• 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
• Western Nephrology and Metabolic Bone Disease, PC — Thornton, Colorado, United States
• Soundview Research Associates — Norwalk, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• MedStar Clinical Research Center — Washington D.C., District of Columbia, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• The Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• FPA Clinical Research — Kissimmee, Florida, United States
• Pines Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Rocky Mountain Diabetes and Osteoporosis Center, PA — Idaho Falls, Idaho, United States
• Renal Associate of Baton Rouge — Baton Rouge, Louisiana, United States
• Intermed — Portland, Maine, United States
• MODEL Clinical Research — Baltimore, Maryland, United States
• Renal Unit, Joslin Diabetes Center — Boston, Massachusetts, United States
• Fallon Clinic Inc. at Worcester Medical Center, Department of Nephrology — Worchester, Massachusetts, United States
• Center for Urban and African American Health — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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