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

This study has been completed.
Sponsor:
Information provided by:
FibroGen
ClinicalTrials.gov Identifier:
NCT00102297
First received: January 26, 2005
Last updated: December 10, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Diabetes Mellitus
Drug: FG-3019
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: 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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Safety
  • Tolerability
  • Pharmacokinetics

Secondary Outcome Measures:
  • Bioactivity on urinary and plasma markers

Estimated Enrollment: 20
Study Start Date: January 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102297

Locations
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
FibroGen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102297     History of Changes
Other Study ID Numbers: FGCL-MC3019-003
Study First Received: January 26, 2005
Last Updated: December 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
Incipient Nephropathy
Type 1 or Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014