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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754143
• Other study ID #: FGCL-3019-029
• Status: Completed
• Phase: Phase 1
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2019
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• FG-3019
Placebo every 2 weeks IV for all infusions
• FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of FG-3019		34 weeks
Secondary	Pharmacokinetic parameters		34 weeks
Secondary	Change from baseline in first morning urinary albumin creatinine ratio (ACR)		6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)