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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754143
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
FibroGen

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Nephropathy Drug: FG-3019 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety and tolerability of FG-3019 [ Time Frame: 34 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 34 weeks ]
  2. Change from baseline in first morning urinary albumin creatinine ratio (ACR) [ Time Frame: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754143


Locations
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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, 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
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT00754143    
Other Study ID Numbers: FGCL-3019-029
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Keywords provided by FibroGen:
Type 1 or Type 2 diabetes
proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs