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Study of FG-3019 in Subjects With Type 2 DM and KD on ACEi and/or ARB Therapy

This study has been terminated.
(Sub-optimal study design)
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT00913393
First received: June 2, 2009
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Diabetic Kidney Disease
 Drug: FG-3019
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background ACEi and/or ARB Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: Safety and tolerability of FG-3019 in the study population. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo IV
 Drug: Placebo
Placebo IV every 2 weeks for 22 weeks
Experimental: 2
3 mg/kg FG-3019 IV
 Drug: FG-3019
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Experimental: 3
10 mg/kg FG-3019 IV
 Drug: FG-3019
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks

Detailed Description:

The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Signed written informed consent
  2. Males and females 18-75 years of age, inclusive
  3. Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
  4. 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
  5. Estimated glomerular filtration rate (eGFR) (by MDRD equation) >20 mL/min/1.73 m2
  6. Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
  7. Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period

Key Exclusion Criteria:

  1. Females who are pregnant or breast feeding
  2. Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
  3. History of New York Heart Association class III/IV heart failure
  4. Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
  5. History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
  6. History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
  7. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or >2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
  8. Hemoglobin <10 g/dL
  9. Hemoglobin A1c (HbA1c) >9 %
  10. Low density lipoprotein (LDL) >130 mg/dL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913393

  Show 28 Study Locations
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT00913393     History of Changes
Other Study ID Numbers: FGCL-3019-032
Study First Received: June 2, 2009
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 17, 2013