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

July 31, 2019 updated by: FibroGen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

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
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tempe, Arizona, United States
    • California
      • La Mesa, California, United States
      • Torrance, California, United States
    • Florida
      • Kissimmee, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Flushing, New York, United States
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Fairfax, Virginia, 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: A
Placebo
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
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
Experimental: B
FG-3019 5 mg/kg
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
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
Experimental: C
FG-3019 10 mg/kg
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of FG-3019
Time Frame: 34 weeks
34 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters
Time Frame: 34 weeks
34 weeks
Change from baseline in first morning urinary albumin creatinine ratio (ACR)
Time Frame: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)
6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)

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

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGCL-3019-029

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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