Type 2 Diabetes MellitusPhase 2NCT00913393
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
A Phase 2 study testing FG-3019 in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Kyntra Bio at 28 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Kidney Disease
- 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
- 46 participants
- Where
- 28 sitesUnited States
- Study dates
- Feb 2009to Jun 2010
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Males and females 18-75 years of age, inclusive
- Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
- 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
- Estimated glomerular filtration rate (eGFR) (by MDRD equation) >20 mL/min/1.73 m2
- Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
- Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period
Who cannot join
- Females who are pregnant or breast feeding
- Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
- History of New York Heart Association class III/IV heart failure
- Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
- History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
- History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
Show all 10Show fewer
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or >2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
- Hemoglobin <10 g/dL
- Hemoglobin A1c (HbA1c) >9 %
- Low density lipoprotein (LDL) >130 mg/dL
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Atlanta, Georgia
Study site
Berlin, New Jersey
Study site
Buena Park, California
Study site
Buffalo, New York
Study site
Chattanooga, Tennessee
Study site
Dallas, Texas
Study site
Evergreen Park, Illinois
Study site
Fairfax, Virginia
Study site
Flushing, New York
Study site
Greenville, North Carolina
Study site
Houston, Texas
Study site
Kenner, Louisiana
Study site
Knoxville, Tennessee
Study site
Lakewood, California
Study site
Lincoln, Nebraska
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Sacramento, California
Study site
Saint Clair Shores, Michigan
Study site
San Antonio, Texas
Study site
Spokane, Washington
Study site
Springfield, Massachusetts
Study site
Tempe, Arizona
Study site
Toledo, Ohio
Study site
Topeka, Kansas
Study site
Walnut Creek, California
Study site
Whittier, California
Study site
Wichita, Kansas
About this study
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy
The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.
Read the detailed description
The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).
- Being tested
- FG-3019, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-3019Drug
3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
FG-3019Drug
10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
PlaceboDrug
Placebo IV every 2 weeks for 22 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo IV Receives: Drug: Placebo |
| 2 | Experimental | 3 mg/kg FG-3019 IV Receives: Drug: FG-3019 |
| 3 | Experimental | 10 mg/kg FG-3019 IV Receives: Drug: FG-3019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Measured: 6 months
Secondary outcomes (3)
Measure: Safety and tolerability of FG-3019 in the study population.
Measured: 12 months
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
Measured: 6 months
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- NCT00913393
- Sponsor's protocol ID
- FGCL-3019-032
- Status last verified
- Feb 2019
- First submitted
- 2 Jun 2009
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
PubMed 41805697
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy
- ClinicalTrials.gov ID
- NCT00913393
- Acronym / sponsor ID
- FGCL-3019-032
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 Jun 2009 (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 effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.
Detailed description
The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo IV |
| 2 | Experimental | Drug: FG-30193 mg/kg FG-3019 IV |
| 3 | Experimental | Drug: FG-301910 mg/kg FG-3019 IV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent
- Males and females 18-75 years of age, inclusive
- Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
- 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
- Estimated glomerular filtration rate (eGFR) (by MDRD equation) >20 mL/min/1.73 m2
Key exclusion criteria (10 listed)
- Females who are pregnant or breast feeding
- Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
- History of New York Heart Association class III/IV heart failure
- Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
- History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
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-30193 mg/kg FG-3019 IV every 2 weeks for 22 weeks | Drug | 2 |
| FG-301910 mg/kg FG-3019 IV every 2 weeks for 22 weeks | Drug | 3 |
| PlaceboPlacebo IV every 2 weeks for 22 weeks | Drug | 1 |
Primary outcome
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Time frame: 6 months
3 secondary outcomes
Measure: Safety and tolerability of FG-3019 in the study population.
Time frame: 12 months
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
Time frame: 6 months
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 41805697Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
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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.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FG-3019 in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Kyntra Bio at 28 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 10 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: stopped early, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.). Results are not available in the source record.
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?
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913393, which also lists 1 linked publication.
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 22 Feb 2019.