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

Sponsor

FibroGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00102297

Collaborator

(none)

Enrollment

Locations

28.9

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: FG-3019	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Safety []
Tolerability []
Pharmacokinetics []

Secondary Outcome Measures

Bioactivity on urinary and plasma markers []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA - LA BioMed	Los Angeles	California	United States	90502
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Radiant Research	Dallas	Texas	United States	75231
4	Diabetes & Glandular Disease	San Antonio	Texas	United States	78229
5	University of Virginia	Charlottesville	Virginia	United States	22908