Clinical trial NCT00754143: Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Diabetic Nephropathy
Keywords: Type 1 or Type 2 diabetes
proteinuria
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of FG-3019
timeFrame: 34 weeks
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: 34 weeks
measure: Change from baseline in first morning urinary albumin creatinine ratio (ACR)
timeFrame: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tempe
country: United States
state: Arizona
city: La Mesa
country: United States
state: California
city: Torrance
country: United States
state: California
city: Kissimmee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Springfield
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
Study officials:
References: