AlbuminuriaPhase 2NCT00312780
Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
A Phase 2 study testing XL784 in people with Albuminuria and Diabetic Nephropathy, run by Symphony Evolution, Inc. at 45 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Albuminuria, Diabetic Nephropathy
- What is being tested?
- XL784
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 45 sitesUnited States
- Study dates
- Mar 2006to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
MODEL Clinical Research
Baltimore, Maryland, 21204
Renal Associate of Baton Rouge
Baton Rouge, Louisiana, 70809
Parkway Medical Center
Birmingham, Alabama, 35215
Renal Unit, Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Virginia Health System, Nephrology Division
Charlottesville, Virginia, 22908
International Clinical Research Network, Inc.
Chula Vista, California, 91911
Division of Nephrology/Department of Medicine, Case Western Rserve University, MetroHealth Medical Center Campus
Cleveland, Ohio, 44109
The Ohio State University Medical Center, Division of Nephrology
Columbus, Ohio, 43210
Clinical Research of South Florida
Coral Gables, Florida, 33134
Center for Urban and African American Health
Detroit, Michigan, 48201
Duke South
Durham, North Carolina, 27710
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651
South Mississippi Nephrology
Gulfport, Mississippi, 39501
Winston Technology, Inc.
Haleyville, Alabama, 35565
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, 83404
Kansas City VA Medical Center
Kansas City, Missouri, 64128
FPA Clinical Research
Kissimmee, Florida, 34741
Scripps Clinic, Torrey Pines, Division of Nephrology
La Jolla, California, 92037
Western Nephrology and Metabolic Bone Disease, PC
Lakewood, Colorado, 80214
National Research Institute
Los Angeles, California, 90057
West Los Angeles VA Medical Center
Los Angeles, California, 90073
UCLA Medical Center, Center for the Health Sciences
Los Angeles, California, 90095
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Diabetes Center of the Southwest
Midland, Texas, 79705
Zablocki Veterans Affairs Medical Center, Nephrology Section
Milwaukee, Wisconsin, 53295
Nephrology Associates, PC
Nashville, Tennessee, 37205
Heartland Medical, PC
New Tazewell, Tennessee, 37825
Soundview Research Associates
Norwalk, Connecticut, 06850
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
Creighton Dibetes Center
Omaha, Nebraska, 68131
University of Nebraska Medical Center - Nephrology
Omaha, Nebraska, 68198
Arroyo Research Inc.
Pasadena, California, 91105
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028
Redpoint Research
Phoenix, Arizona, 85209
Intermed
Portland, Maine, 04102
dgd Research
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Clayton Medical Research
St Louis, Missouri, 63117
Montefiore Medical Center
The Bronx, New York, 10461
Western Nephrology and Metabolic Bone Disease, PC
Thornton, Colorado, 80260
MedStar Clinical Research Center
Washington D.C., District of Columbia, 20003
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
LAND Clinical Studies, LLC
West Caldwell, New Jersey, 07006
Fallon Clinic Inc. at Worcester Medical Center, Department of Nephrology
Worchester, Massachusetts, 01608
About this study
Official title: 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.
- Conditions
- Albuminuria, Diabetic Nephropathy
- Being tested
- XL784
- Keywords
- albuminuria, diabetic nephropathy, diabetes
- Medical subject headings
- Albuminuria, Diabetic Nephropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL784Drug
XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: XL784 | Experimental | Not described Receives: Drug: XL784 |
| Arm 2: Placebo Gel capsules | Placebo comparator | Not described Receives: Drug: XL784 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in albumin excretion relative to creatinine
Measured: 27 weeks
Secondary outcomes (2)
Safety and tolerability
Measured: 27 weeks
Pharmacokinetics and renal elimination
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symphony Evolution, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sanjay K Aggarwal, MD, MBA, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312780
- Sponsor's protocol ID
- XL784-201
- Status last verified
- Feb 2010
- First submitted
- 7 Apr 2006
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00312780
- Acronym / sponsor ID
- XL784-201
- Conditions
- Albuminuria, Diabetic Nephropathy
- Keywords
- albuminuria, diabetic nephropathy, diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: XL784 | Experimental | Drug: XL784 |
| Arm 2: Placebo Gel capsules | Placebo comparator | Drug: XL784 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XL784XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules) | Drug | Arm 1: XL784, Arm 2: Placebo Gel capsules |
Primary outcome
Reduction in albumin excretion relative to creatinine
Time frame: 27 weeks
2 secondary outcomes
Safety and tolerability
Time frame: 27 weeks
Pharmacokinetics and renal elimination
Time frame: 27 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay K Aggarwal, MD, MBA study director
Exelixis
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XL784 in people with Albuminuria and Diabetic Nephropathy, run by Symphony Evolution, Inc. at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in albumin excretion relative to creatinine (time frame: 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2010.