Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
- Registration Number
- NCT00312780
- Lead Sponsor
- Symphony Evolution, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: XL784 XL784 - Arm 2: Placebo Gel capsules XL784 -
- Primary Outcome Measures
Name Time Method Reduction in albumin excretion relative to creatinine 27 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability 27 weeks Pharmacokinetics and renal elimination 27 weeks
Trial Locations
- Locations (44)
Rocky Mountain Diabetes and Osteoporosis Center, PA
🇺🇸Idaho Falls, Idaho, United States
The Center for Diabetes and Endocrine Care
🇺🇸Hollywood, Florida, United States
Pines Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
MODEL Clinical Research
🇺🇸Baltimore, Maryland, United States
Scripps Clinic, Torrey Pines, Division of Nephrology
🇺🇸La Jolla, California, United States
West Los Angeles VA Medical Center
🇺🇸Los Angeles, California, United States
International Clinical Research Network, Inc.
🇺🇸Chula Vista, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
National Research Institute
🇺🇸Los Angeles, California, United States
UCLA Medical Center, Center for the Health Sciences
🇺🇸Los Angeles, California, United States
Fallon Clinic Inc. at Worcester Medical Center, Department of Nephrology
🇺🇸Worchester, Massachusetts, United States
LAND Clinical Studies, LLC
🇺🇸West Caldwell, New Jersey, United States
Arroyo Research Inc.
🇺🇸Pasadena, California, United States
Intermed
🇺🇸Portland, Maine, United States
The Ohio State University Medical Center, Division of Nephrology
🇺🇸Columbus, Ohio, United States
Winston Technology, Inc.
🇺🇸Haleyville, Alabama, United States
Soundview Research Associates
🇺🇸Norwalk, Connecticut, United States
South Mississippi Nephrology
🇺🇸Gulfport, Mississippi, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
Western Nephrology and Metabolic Bone Disease, PC
🇺🇸Thornton, Colorado, United States
MedStar Clinical Research Center
🇺🇸Washington, District of Columbia, United States
Renal Associate of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Clayton Medical Research
🇺🇸St. Louis, Missouri, United States
Mountain View Clinical Research, Inc.
🇺🇸Greer, South Carolina, United States
Diabetes Center of the Southwest
🇺🇸Midland, Texas, United States
Heartland Medical, PC
🇺🇸New Tazewell, Tennessee, United States
University of Virginia Health System, Nephrology Division
🇺🇸Charlottesville, Virginia, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Renal Unit, Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Redpoint Research
🇺🇸Phoenix, Arizona, United States
Nephrology Associates, PC
🇺🇸Nashville, Tennessee, United States
dgd Research
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Center for Urban and African American Health
🇺🇸Detroit, Michigan, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Creighton Dibetes Center
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center - Nephrology
🇺🇸Omaha, Nebraska, United States
Duke South
🇺🇸Durham, North Carolina, United States
Division of Nephrology/Department of Medicine, Case Western Rserve University, MetroHealth Medical Center Campus
🇺🇸Cleveland, Ohio, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Zablocki Veterans Affairs Medical Center, Nephrology Section
🇺🇸Milwaukee, Wisconsin, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States