Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
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
1 other identifier
interventional
38
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus
Started Mar 2008
Typical duration for phase_1 diabetes-mellitus
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 2, 2019
July 1, 2019
1.8 years
September 15, 2008
July 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of FG-3019
34 weeks
Secondary Outcomes (2)
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)
Study Arms (3)
A
PLACEBO COMPARATORPlacebo
B
EXPERIMENTALFG-3019 5 mg/kg
C
EXPERIMENTALFG-3019 10 mg/kg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
Study Sites (18)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Kissimmee, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Fairfax, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2008
First Posted
September 17, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 2, 2019
Record last verified: 2019-07