Diabetes MellitusPhase 1NCT00754143
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
A Phase 1 study testing FG-3019 in people with Diabetes Mellitus and Diabetic Nephropathy, run by Kyntra Bio at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Nephropathy
- What is being tested?
- FG-3019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Atlanta, Georgia
Study site
Birmingham, Alabama
Study site
Chapel Hill, North Carolina
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Fairfax, Virginia
Study site
Flushing, New York
Study site
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Kissimmee, Florida
Study site
La Mesa, California
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Springfield, Massachusetts
Study site
Tempe, Arizona
Study site
Torrance, California
About this study
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
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.
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Being tested
- FG-3019
- Keywords
- Type 1 or Type 2 diabetes, proteinuria
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Diabetes Mellitus, Type 2, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-3019Drug
Placebo every 2 weeks IV for all infusions
FG-3019Drug
FG-3019 5 mg/kg every 2 weeks IV for all infusions
FG-3019Drug
FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo Receives: Drug: FG-3019 |
| B | Experimental | FG-3019 5 mg/kg Receives: Drug: FG-3019 |
| C | Experimental | FG-3019 10 mg/kg Receives: Drug: FG-3019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of FG-3019
Measured: 34 weeks
Secondary outcomes (2)
Pharmacokinetic parameters
Measured: 34 weeks
Change from baseline in first morning urinary albumin creatinine ratio (ACR)
Measured: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754143
- Sponsor's protocol ID
- FGCL-3019-029
- Status last verified
- Jul 2019
- First submitted
- 15 Sep 2008
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00754143
- Acronym / sponsor ID
- FGCL-3019-029
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Keywords
- Type 1 or Type 2 diabetes, proteinuria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: FG-3019Placebo |
| B | Experimental | Drug: FG-3019FG-3019 5 mg/kg |
| C | Experimental | Drug: FG-3019FG-3019 10 mg/kg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG-3019Placebo every 2 weeks IV for all infusions | Drug | A |
| FG-3019FG-3019 5 mg/kg every 2 weeks IV for all infusions | Drug | B |
| FG-3019FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71 | Drug | C |
Primary outcome
Safety and tolerability of FG-3019
Time frame: 34 weeks
2 secondary outcomes
Pharmacokinetic parameters
Time frame: 34 weeks
Change from baseline in first morning urinary albumin creatinine ratio (ACR)
Time frame: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FG-3019 in people with Diabetes Mellitus and Diabetic Nephropathy, run by Kyntra Bio at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of FG-3019 (time frame: 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.