Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

December 10, 2007 updated by: FibroGen

A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

The Phase 1b study is a multi-center trial designed to test the safety, tolerability, biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2 diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or 10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses. The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a secondary endpoint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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
    • California
      • Los Angeles, California, United States, 90502
        • UCLA - LA BioMed
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Radiant Research
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Body mass index not exceeding 32.0 kg/m2
  • If female, subject must meet one of the following criteria: a) surgically sterile (hysterectomy or bilateral tubal ligation) OR b) at least two years postmenopausal OR c) using a dual method of contraception and have a negative serum pregnancy test if of childbearing potential
  • Diagnosis of type 1 or type 2 diabetes according to the American Diabetes Association
  • Fasting plasma glucose of ≥ 126 mg/dL or current treatment with oral hypoglycemic agents or insulin
  • Microalbuminuria defined as albumin to creatinine ratio in a spot collection (first void) of 30 - 300 mg/gram confirmed by two samples two to three days apart
  • Serum creatinine of no more than 1.5 mg/dL for men and no more than 1.1 mg/dL for women

Exclusion Criteria:

  • Female subjects who are pregnant or lactating
  • Non-diabetic renal disease
  • History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine monoclonal antibodies
  • Coronary artery bypass graft surgery, myocardial infarction, cerebrovascular accident, percutaneous transluminal angioplasty, transient ischemic attack, history of unstable angina, known heart failure, uncontrolled cardiac arrhythmia, or uncontrolled hypertension within six months prior to Day 0
  • Bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal
  • History of cancer of any type in the past 5 years, except non- melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
  • Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study
  • Trauma or surgical procedures (including dental) within six months prior to Day 0
  • Planned elective surgery during the study and for 3 months following the end of the study
  • Participation in studies of investigational drugs within 6 weeks prior to first dose

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: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Pharmacokinetics
Tolerability

Secondary Outcome Measures

Outcome Measure
Bioactivity on urinary and plasma markers

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

January 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 26, 2005

First Submitted That Met QC Criteria

January 26, 2005

First Posted (Estimate)

January 27, 2005

Study Record Updates

Last Update Posted (Estimate)

December 12, 2007

Last Update Submitted That Met QC Criteria

December 10, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGCL-MC3019-003

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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