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

Phase 1

Completed

• Conditions: Diabetes Mellitus; Diabetic Nephropathy
• Interventions: Drug: FG-3019

• Registration Number: NCT00754143
• Lead Sponsor: FibroGen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-17
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	FG-3019	FG-3019 10 mg/kg
B	FG-3019	FG-3019 5 mg/kg
A	FG-3019	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of FG-3019	34 weeks

Secondary Outcome Measures

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