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

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00312780

Purpose

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.

Condition	Intervention	Phase
Albuminuria Diabetic Nephropathy	Drug: XL784	Phase II

MedlinePlus related topics: Diabetic Kidney Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy

Further study details as provided by Exelixis:

Primary Outcome Measures:

Reduction in albumin excretion relative to creatinine

Secondary Outcome Measures:

Safety and tolerability
Pharmacokinetics and renal elimination

Estimated Enrollment:	132
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312780

Show 47 Study Locations

Sponsors and Collaborators

Exelixis

More Information

Study ID Numbers:	XL784-201
Study First Received:	April 7, 2006
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00312780
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

albuminuria
diabetic nephropathy
diabetes

Study placed in the following topic categories:

Signs and Symptoms
Proteinuria
Albuminuria
Diabetic Nephropathies
Urologic Diseases
Urination Disorders

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Diabetes Complications

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009