Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy - Tabular View

Tracking Information
First Received Date ^ICMJE	April 7, 2006
Last Updated Date	July 30, 2009
Start Date ^ICMJE	March 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2006)	Reduction in albumin excretion relative to creatinine
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00312780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2006)	Safety and tolerability Pharmacokinetics and renal elimination
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Albuminuria Diabetic Nephropathy
Intervention ^ICMJE	Drug: XL784
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	132
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00312780
Responsible Party	Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Study ID Numbers ^ICMJE	XL784-201
Study Sponsor ^ICMJE	Symphony Evolution, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Symphony Evolution, Inc.
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP