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Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
This study is ongoing, but not recruiting participants.
First Received: September 15, 2008   Last Updated: July 14, 2009   History of Changes
Sponsor: FibroGen
Information provided by: FibroGen
ClinicalTrials.gov Identifier: NCT00754143
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Diabetic Nephropathy
Drug: FG-3019
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Safety and tolerability of FG-3019 [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator
Placebo
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
B: Experimental
FG-3019 5 mg/kg
Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
C: Experimental
FG-3019 10 mg/kg
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754143

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tempe, Arizona, United States
United States, California
La Mesa, California, United States
Torrance, California, United States
United States, Florida
Kissimmee, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
Flushing Queens, New York, United States
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
Dallas, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: FibroGen, Inc. ( Sandy Liaw, Senior Clinical Program Manager )
Study ID Numbers: FGCL-3019-029
Study First Received: September 15, 2008
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00754143     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
Type 1 or Type 2 diabetes
proteinuria

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

ClinicalTrials.gov processed this record on February 08, 2010