Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
FibroGen
ClinicalTrials.gov Identifier:
NCT00754143
First received: September 15, 2008
Last updated: January 10, 2011
Last verified: January 2011

September 15, 2008
January 10, 2011
March 2008
December 2009   (final data collection date for primary outcome measure)
Safety and tolerability of FG-3019 [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00754143 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in first morning urinary albumin creatinine ratio (ACR) [ Time Frame: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy

The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Diabetic Nephropathy
  • Drug: FG-3019
    Placebo every 2 weeks IV for all infusions
  • Drug: FG-3019
    FG-3019 5 mg/kg every 2 weeks IV for all infusions
  • Drug: FG-3019
    FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
  • Placebo Comparator: A
    Placebo
    Intervention: Drug: FG-3019
  • Experimental: B
    FG-3019 5 mg/kg
    Intervention: Drug: FG-3019
  • Experimental: C
    FG-3019 10 mg/kg
    Intervention: Drug: FG-3019
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-80 years, inclusive
  2. Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
  3. First morning urinary ACR >0.200 g/g
  4. Receiving stable doses of ACEi and/or ARB therapy prior to Screening
  5. Estimated glomerular filtration rate of ≥20 and <90 mL/min/1.73 m2
  6. Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
  7. Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization

Exclusion Criteria:

  1. Female subjects who are pregnant or breastfeeding
  2. Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants
  3. Any history of New York Heart Association (NYHA) class III/IV heart failure (HF)
  4. Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression
  5. Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction)
  6. History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
  7. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
  8. Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening
  9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal
  10. Hemoglobin <10 g/dL
  11. Positive for HIV (IgG) antibody
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00754143
FGCL-3019-029
Yes
Sandy Liaw, Senior Clinical Program Manager, FibroGen, Inc.
FibroGen
Not Provided
Not Provided
FibroGen
January 2011

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