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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Placebo
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
Experimental: B
FG-3019 5 mg/kg
Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
Experimental: C
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
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: 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
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: Sandy Liaw, Senior Clinical Program Manager, FibroGen, Inc.
ClinicalTrials.gov Identifier: NCT00754143     History of Changes
Other Study ID Numbers: FGCL-3019-029
Study First Received: September 15, 2008
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 30, 2014