Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy
1 other identifier
interventional
125
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2006
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 7, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 23, 2010
February 1, 2010
1.6 years
April 7, 2006
February 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in albumin excretion relative to creatinine
27 weeks
Secondary Outcomes (2)
Safety and tolerability
27 weeks
Pharmacokinetics and renal elimination
27 weeks
Study Arms (2)
Arm 1: XL784
EXPERIMENTALArm 2: Placebo Gel capsules
PLACEBO COMPARATORInterventions
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Winston Technology, Inc.
Haleyville, Alabama, 35565, United States
Redpoint Research
Phoenix, Arizona, 85209, United States
International Clinical Research Network, Inc.
Chula Vista, California, 91911, United States
Scripps Clinic, Torrey Pines, Division of Nephrology
La Jolla, California, 92037, United States
National Research Institute
Los Angeles, California, 90057, United States
West Los Angeles VA Medical Center
Los Angeles, California, 90073, United States
UCLA Medical Center, Center for the Health Sciences
Los Angeles, California, 90095, United States
Arroyo Research Inc.
Pasadena, California, 91105, United States
Western Nephrology and Metabolic Bone Disease, PC
Lakewood, Colorado, 80214, United States
Western Nephrology and Metabolic Bone Disease, PC
Thornton, Colorado, 80260, United States
Soundview Research Associates
Norwalk, Connecticut, 06850, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, 20003, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028, United States
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, 83404, United States
Renal Associate of Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Intermed
Portland, Maine, 04102, United States
MODEL Clinical Research
Baltimore, Maryland, 21204, United States
Renal Unit, Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Fallon Clinic Inc. at Worcester Medical Center, Department of Nephrology
Worchester, Massachusetts, 01608, United States
Center for Urban and African American Health
Detroit, Michigan, 48201, United States
South Mississippi Nephrology
Gulfport, Mississippi, 39501, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Clayton Medical Research
St Louis, Missouri, 63117, United States
Creighton Dibetes Center
Omaha, Nebraska, 68131, United States
University of Nebraska Medical Center - Nephrology
Omaha, Nebraska, 68198, United States
LAND Clinical Studies, LLC
West Caldwell, New Jersey, 07006, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Duke South
Durham, North Carolina, 27710, United States
Division of Nephrology/Department of Medicine, Case Western Rserve University, MetroHealth Medical Center Campus
Cleveland, Ohio, 44109, United States
The Ohio State University Medical Center, Division of Nephrology
Columbus, Ohio, 43210, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651, United States
Nephrology Associates, PC
Nashville, Tennessee, 37205, United States
Heartland Medical, PC
New Tazewell, Tennessee, 37825, United States
Diabetes Center of the Southwest
Midland, Texas, 79705, United States
dgd Research
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Virginia Health System, Nephrology Division
Charlottesville, Virginia, 22908, United States
Zablocki Veterans Affairs Medical Center, Nephrology Section
Milwaukee, Wisconsin, 53295, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sanjay K Aggarwal, MD, MBA
Exelixis
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 7, 2006
First Posted
April 11, 2006
Study Start
March 1, 2006
Primary Completion
October 1, 2007
Study Completion
December 1, 2007
Last Updated
February 23, 2010
Record last verified: 2010-02