Clinical Trial: Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy
Brief 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. 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.
Detailed Summary:
Sponsor: Symphony Evolution, Inc.
Current Primary Outcome: Reduction in albumin excretion relative to creatinine [ Time Frame: 27 weeks ]
Original Primary Outcome: Reduction in albumin excretion relative to creatinine
Current Secondary Outcome:
- Safety and tolerability [ Time Frame: 27 weeks ]
- Pharmacokinetics and renal elimination [ Time Frame: 27 weeks ]
Original Secondary Outcome:
- Safety and tolerability
- Pharmacokinetics and renal elimination
Information By: Symphony Evolution, Inc.
Dates:
Date Received: April 7, 2006
Date Started: March 2006
Date Completion:
Last Updated: February 22, 2010
Last Verified: February 2010
