Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy

February 22, 2010 updated by: Symphony Evolution, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Haleyville, Alabama, United States, 35565
        • Winston Technology, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85209
        • Redpoint Research
    • California
      • Chula Vista, California, United States, 91911
        • International Clinical Research Network, Inc.
      • La Jolla, California, United States, 92037
        • Scripps Clinic, Torrey Pines, Division of Nephrology
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Los Angeles, California, United States, 90073
        • West Los Angeles VA Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center, Center for the Health Sciences
      • Pasadena, California, United States, 91105
        • Arroyo Research Inc.
    • Colorado
      • Lakewood, Colorado, United States, 80214
        • Western Nephrology and Metabolic Bone Disease, PC
      • Thornton, Colorado, United States, 80260
        • Western Nephrology and Metabolic Bone Disease, PC
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Soundview Research Associates
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • MedStar Clinical Research Center
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Hollywood, Florida, United States, 33021
        • The Center for Diabetes and Endocrine Care
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research, Inc.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center, PA
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Renal Associate of Baton Rouge
    • Maine
      • Portland, Maine, United States, 04102
        • Intermed
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Model Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Renal Unit, Joslin Diabetes Center
      • Worchester, Massachusetts, United States, 01608
        • Fallon Clinic Inc. at Worcester Medical Center, Department of Nephrology
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Center for Urban and African American Health
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • South Mississippi Nephrology
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
      • St. Louis, Missouri, United States, 63117
        • Clayton Medical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Dibetes Center
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center - Nephrology
    • New Jersey
      • West Caldwell, New Jersey, United States, 07006
        • LAND Clinical Studies, LLC
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke South
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Division of Nephrology/Department of Medicine, Case Western Rserve University, MetroHealth Medical Center Campus
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center, Division of Nephrology
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research, LLC
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Institute of Southern Oregon, PC
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research, Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nephrology Associates, PC
      • New Tazewell, Tennessee, United States, 37825
        • Heartland Medical, PC
    • Texas
      • Midland, Texas, United States, 79705
        • Diabetes Center of the Southwest
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • DGD Research
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System, Nephrology Division
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Zablocki Veterans Affairs Medical Center, Nephrology Section

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: XL784
Drug: XL784
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
PLACEBO_COMPARATOR: Arm 2: Placebo Gel capsules
Drug: XL784
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in albumin excretion relative to creatinine
Time Frame: 27 weeks
27 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 27 weeks
27 weeks
Pharmacokinetics and renal elimination
Time Frame: 27 weeks
27 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symphony Evolution, Inc.

Investigators

  • Study Director: Sanjay K Aggarwal, MD, MBA, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

April 7, 2006

First Submitted That Met QC Criteria

April 7, 2006

First Posted (ESTIMATE)

April 11, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2010

Last Update Submitted That Met QC Criteria

February 22, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL784-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Nephropathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe