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CompletedNCT00102297Updated Dec 12, 2007

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

A Phase 1 interventional study of FG-3019 in Diabetes Mellitus, sponsored by FibroGen. Completed at 5 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-12-12.

Sponsored by FibroGen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
21 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Diabetes Mellitus

Keywords

  • Incipient Nephropathy
  • Type 1 or Type 2 Diabetes
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • DrugFG-3019
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What researchers measure

Primary outcomes

  1. Safety

  2. Tolerability

  3. Pharmacokinetics

Secondary outcomes

  1. Bioactivity on urinary and plasma markers

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00102297
Lead sponsor
FibroGen
First posted
Jan 27, 2005
Start date
Jan 2005
Completion
Jun 2007
Last update
Dec 12, 2007
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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