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CompletedNCT00754143Updated Aug 2, 2019

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

A Phase 1 interventional study of FG-3019 and FG-3019 in Diabetes Mellitus and Diabetic Nephropathy, sponsored by FibroGen. Completed at 18 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by FibroGen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus
  • Diabetic Nephropathy

Keywords

  • Type 1 or Type 2 diabetes
  • proteinuria
03

In context

Kidney Diseases

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

This study's enrollment of 38 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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Placebo comparator
    A

    Placebo

    Drug: FG-3019

  • Experimental
    B

    FG-3019 5 mg/kg

    Drug: FG-3019

  • Experimental
    C

    FG-3019 10 mg/kg

    Drug: FG-3019

Interventions

  • DrugFG-3019

    Placebo every 2 weeks IV for all infusions

  • DrugFG-3019

    FG-3019 5 mg/kg every 2 weeks IV for all infusions

  • DrugFG-3019

    FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of FG-3019

    Time frame: 34 weeks

Secondary outcomes

  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)

07

Study locations

18 sites
  • Birmingham, Alabama, United States
  • Tempe, Arizona, United States
  • La Mesa, California, United States
  • Torrance, California, United States
  • Kissimmee, Florida, United States
  • Atlanta, Georgia, United States
  • Springfield, Massachusetts, United States
  • Omaha, Nebraska, United States
  • Flushing, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Hershey, Pennsylvania, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00754143
Lead sponsor
FibroGen
Responsible party
Sponsor
First posted
Sep 17, 2008
Start date
Mar 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Aug 2, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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