Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy

February 20, 2019 updated by: FibroGen

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 Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States
    • California
      • Buena Park, California, United States
      • Lakewood, California, United States
      • Sacramento, California, United States
      • Walnut Creek, California, United States
      • Whittier, California, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Evergreen Park, Illinois, United States
    • Kansas
      • Topeka, Kansas, United States
      • Wichita, Kansas, United States
    • Louisiana
      • Kenner, Louisiana, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Saint Clair Shores, Michigan, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Jersey
      • Berlin, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • Flushing, New York, United States
      • New York, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
    • Ohio
      • Toledo, Ohio, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Knoxville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: FG-3019
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Experimental: 3
10 mg/kg FG-3019 IV
Drug: FG-3019
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
Drug: FG-3019
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: Safety and tolerability of FG-3019 in the study population.
Time Frame: 12 months
12 months
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
Time Frame: 6 months
6 months
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FibroGen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGCL-3019-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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