Skip to main content
OpenTrials
Completed

NCT Number: NCT00312780

Study of XL784 in Patients 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Albuminuria Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Parkway Medical Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XL784

Drug

XL784 softgel capsules (100 mg per capsule) orally administered at a dose of 200 mg/day (or placebo softgel capsules)

Primary outcomes

  1. Reduction in albumin excretion relative to creatinine

    Time frame: 27 weeks

Secondary outcomes

  1. Safety and tolerability

    Time frame: 27 weeks

  2. Pharmacokinetics and renal elimination

    Time frame: 27 weeks

Sponsors and collaborators

Lead sponsor

Symphony Evolution, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 11, 2006
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.