Status:
COMPLETED
Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
Lead Sponsor:
Symphony Evolution, Inc.
Conditions:
Albuminuria
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00312780
Start Date
March 1 2006
End Date
December 1 2007
Last Update
February 23 2010
Active Locations (45)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Winston Technology, Inc.
Haleyville, Alabama, United States, 35565
3
Redpoint Research
Phoenix, Arizona, United States, 85209
4
International Clinical Research Network, Inc.
Chula Vista, California, United States, 91911