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

Sponsor

FibroGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00754143

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: A

Placebo

Drug: FG-3019

Placebo every 2 weeks IV for all infusions

Experimental: B

FG-3019 5 mg/kg

Drug: FG-3019

FG-3019 5 mg/kg every 2 weeks IV for all infusions

Experimental: C

FG-3019 10 mg/kg

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

Outcome Measures

Primary Outcome Measures

Safety and tolerability of FG-3019 [34 weeks]

Secondary Outcome Measures

Pharmacokinetic parameters [34 weeks]
Change from baseline in first morning urinary albumin creatinine ratio (ACR) [6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80 years, inclusive
Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
First morning urinary ACR >0.200 g/g
Receiving stable doses of ACEi and/or ARB therapy prior to Screening
Estimated glomerular filtration rate of ≥20 and <90 mL/min/1.73 m2
Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization

Exclusion Criteria:

Female subjects who are pregnant or breastfeeding
Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants
Any history of New York Heart Association (NYHA) class III/IV heart failure (HF)
Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression
Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction)
History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal
Hemoglobin <10 g/dL
Positive for HIV (IgG) antibody

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Tempe	Arizona	United States
3	La Mesa	California	United States
4	Torrance	California	United States
5	Kissimmee	Florida	United States
6	Atlanta	Georgia	United States
7	Springfield	Massachusetts	United States
8	Omaha	Nebraska	United States
9	Flushing	New York	United States
10	New York	New York	United States
11	Chapel Hill	North Carolina	United States
12	Cleveland	Ohio	United States
13	Portland	Oregon	United States
14	Hershey	Pennsylvania	United States
15	Dallas	Texas	United States
16	Houston	Texas	United States
17	San Antonio	Texas	United States
18	Fairfax	Virginia	United States