Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

NCT ID: NCT00102297

Last Updated: 2007-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-06-30

Brief Summary

The Phase 1b study is a multi-center trial designed to test the safety, tolerability, biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2 diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or 10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses. The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a secondary endpoint.

Conditions

Diabetes Mellitus

Keywords

Incipient Nephropathy; Type 1 or Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

FG-3019

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Body mass index not exceeding 32.0 kg/m2
• If female, subject must meet one of the following criteria: a) surgically sterile (hysterectomy or bilateral tubal ligation) OR b) at least two years postmenopausal OR c) using a dual method of contraception and have a negative serum pregnancy test if of childbearing potential
• Diagnosis of type 1 or type 2 diabetes according to the American Diabetes Association
• Fasting plasma glucose of ≥ 126 mg/dL or current treatment with oral hypoglycemic agents or insulin
• Microalbuminuria defined as albumin to creatinine ratio in a spot collection (first void) of 30 - 300 mg/gram confirmed by two samples two to three days apart
• Serum creatinine of no more than 1.5 mg/dL for men and no more than 1.1 mg/dL for women

Exclusion Criteria

• Female subjects who are pregnant or lactating
• Non-diabetic renal disease
• History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine monoclonal antibodies
• Coronary artery bypass graft surgery, myocardial infarction, cerebrovascular accident, percutaneous transluminal angioplasty, transient ischemic attack, history of unstable angina, known heart failure, uncontrolled cardiac arrhythmia, or uncontrolled hypertension within six months prior to Day 0
• Bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal
• History of cancer of any type in the past 5 years, except non- melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
• Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study
• Trauma or surgical procedures (including dental) within six months prior to Day 0
• Planned elective surgery during the study and for 3 months following the end of the study
• Participation in studies of investigational drugs within 6 weeks prior to first dose

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: lead

Locations

UCLA - LA BioMed

Los Angeles, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Radiant Research

Dallas, Texas, United States

Diabetes & Glandular Disease

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

FGCL-MC3019-003

Identifier Type: -

Identifier Source: org_study_id