Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
NCT ID: NCT00312780
Last Updated: 2010-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2006-03-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: XL784
XL784
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
Arm 2: Placebo Gel capsules
XL784
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
Interventions
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XL784
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Symphony Evolution, Inc.
INDUSTRY
Responsible Party
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Symphony Evolution, Inc.
Principal Investigators
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Sanjay K Aggarwal, MD, MBA
Role: STUDY_DIRECTOR
Exelixis
Locations
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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
South Mississippi Nephrology
Gulfport, Mississippi, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Clayton Medical Research
St Louis, Missouri, United States
Creighton Dibetes Center
Omaha, Nebraska, United States
University of Nebraska Medical Center - Nephrology
Omaha, Nebraska, United States
LAND Clinical Studies, LLC
West Caldwell, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, 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
The Ohio State University Medical Center, Division of Nephrology
Columbus, Ohio, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, United States
Nephrology Associates, PC
Nashville, Tennessee, United States
Heartland Medical, PC
New Tazewell, Tennessee, United States
Diabetes Center of the Southwest
Midland, Texas, United States
dgd Research
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Virginia Health System, Nephrology Division
Charlottesville, Virginia, United States
Zablocki Veterans Affairs Medical Center, Nephrology Section
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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XL784-201
Identifier Type: -
Identifier Source: org_study_id
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