Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
Albuminuria, Diabetic Nephropathy
About this trial
This is an interventional treatment trial for Albuminuria focused on measuring albuminuria, diabetic nephropathy, diabetes
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Parkway Medical Center
- Winston Technology, Inc.
- Redpoint Research
- International Clinical Research Network, Inc.
- Scripps Clinic, Torrey Pines, Division of Nephrology
- National Research Institute
- West Los Angeles VA Medical Center
- UCLA Medical Center, Center for the Health Sciences
- Arroyo Research Inc.
- Western Nephrology and Metabolic Bone Disease, PC
- Western Nephrology and Metabolic Bone Disease, PC
- Soundview Research Associates
- Chase Medical Research, LLC
- MedStar Clinical Research Center
- Clinical Research of South Florida
- The Center for Diabetes and Endocrine Care
- FPA Clinical Research
- Pines Clinical Research, Inc.
- Rocky Mountain Diabetes and Osteoporosis Center, PA
- Renal Associate of Baton Rouge
- Intermed
- MODEL Clinical Research
- Renal Unit, Joslin Diabetes Center
- Fallon Clinic Inc. at Worcester Medical Center, Department of Nephrology
- Center for Urban and African American Health
- South Mississippi Nephrology
- Kansas City VA Medical Center
- Clayton Medical Research
- Creighton Dibetes Center
- University of Nebraska Medical Center - Nephrology
- LAND Clinical Studies, LLC
- Montefiore Medical Center
- Duke South
- Division of Nephrology/Department of Medicine, Case Western Rserve University, MetroHealth Medical Center Campus
- The Ohio State University Medical Center, Division of Nephrology
- COR Clinical Research, LLC
- Clinical Research Institute of Southern Oregon, PC
- Mountain View Clinical Research, Inc.
- Nephrology Associates, PC
- Heartland Medical, PC
- Diabetes Center of the Southwest
- dgd Research
- University of Texas Health Science Center at San Antonio
- University of Virginia Health System, Nephrology Division
- Zablocki Veterans Affairs Medical Center, Nephrology Section
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1: XL784
Arm 2: Placebo Gel capsules