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

January 26, 2005
December 10, 2007
January 2005
Not Provided
  • Safety
  • Tolerability
  • Pharmacokinetics
Same as current
Complete list of historical versions of study NCT00102297 on ClinicalTrials.gov Archive Site
Bioactivity on urinary and plasma markers
Same as current
Not Provided
Not Provided
 
Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: FG-3019
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2007
Not Provided

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
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102297
FGCL-MC3019-003
Not Provided
Not Provided
FibroGen
Not Provided
Not Provided
FibroGen
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP