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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102297
Recruitment Status : Completed
First Posted : January 27, 2005
Last Update Posted : December 12, 2007
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: FG-3019 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus
Study Start Date : January 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Primary Outcome Measures :
  1. Safety
  2. Tolerability
  3. Pharmacokinetics

Secondary Outcome Measures :
  1. Bioactivity on urinary and plasma markers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00102297

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United States, California
UCLA - LA BioMed
Los Angeles, California, United States, 90502
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Texas
Radiant Research
Dallas, Texas, United States, 75231
Diabetes & Glandular Disease
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00102297    
Other Study ID Numbers: FGCL-MC3019-003
First Posted: January 27, 2005    Key Record Dates
Last Update Posted: December 12, 2007
Last Verified: December 2007
Keywords provided by FibroGen:
Incipient Nephropathy
Type 1 or Type 2 Diabetes
Additional relevant MeSH terms:
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Kidney Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs