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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Reduction in albumin excretion relative to creatinine
Time Frame: 27 weeks
27 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Symphony Evolution, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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