Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
This study has been completed.
Sponsor:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00312780
First Posted: April 11, 2006
Last Update Posted: February 23, 2010
Information provided by:
Symphony Evolution, Inc.
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy |
Resource links provided by NLM:
Further study details as provided by Symphony Evolution, Inc.:
Primary Outcome Measures:
- Reduction in albumin excretion relative to creatinine [ Time Frame: 27 weeks ]
Secondary Outcome Measures:
- Safety and tolerability [ Time Frame: 27 weeks ]
- Pharmacokinetics and renal elimination [ Time Frame: 27 weeks ]
| Enrollment: | 125 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312780
Show 45 Study Locations
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
| Study Director: | Sanjay K Aggarwal, MD, MBA | Exelixis |
More Information
| Responsible Party: | Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc. |
| ClinicalTrials.gov Identifier: | NCT00312780 History of Changes |
| Other Study ID Numbers: |
XL784-201 |
| First Submitted: | April 7, 2006 |
| First Posted: | April 11, 2006 |
| Last Update Posted: | February 23, 2010 |
| Last Verified: | February 2010 |
Keywords provided by Symphony Evolution, Inc.:
|
albuminuria diabetic nephropathy diabetes |
Additional relevant MeSH terms:
|
Diabetic Nephropathies Kidney Diseases Albuminuria Urologic Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Proteinuria Urination Disorders Urological Manifestations Signs and Symptoms |