Focal Segmental GlomerulosclerosisPhase 1NCT00782561
Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
A Phase 1 study testing FG-3019 in people with Focal Segmental Glomerulosclerosis, run by Kyntra Bio at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS). Read more about this study
- Who is it for?
- Ages 12 to 64 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- FG-3019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to 18 Jun 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 12 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
- Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
- Age less than or equal to 2 years old at onset of proteinuria
- First morning urine protein/creatinine ratio (U p/c) >1 gm/gm
- Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2
Who cannot join
- Non-FSGS renal disease other than benign cyst; or secondary FSGS
- History of organ transplantation
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
- History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
- Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal
- Hematocrit < 30%
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Chapel Hill, North Carolina, 27599-7155
Study site
Columbus, Ohio, 43205
Study site
New Hyde Park, New York, 11040
About this study
Official title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis
The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- FG-3019
- Keywords
- steroid resistant focal segmental glomerulosclerosis, FSGS, adolescent focal segmental glomerulosclerosis, focal segmental glomerulosclerosis
- Medical subject headings
- Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-3019Drug
FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| FG-3019 | Experimental | FG-3019 5 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 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications
Measured: 32 weeks
Secondary outcomes (2)
Standard plasma and urinary PK parameters
Measured: 32 weeks
Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startApr 2008
- Primary completion18 Jun 2009
- Study completion18 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Segmental GlomerulosclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT00782561
- Sponsor's protocol ID
- FGCL-MC3019-026
- Status last verified
- Jul 2019
- First submitted
- 27 Oct 2008
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis
- ClinicalTrials.gov ID
- NCT00782561
- Acronym / sponsor ID
- FGCL-MC3019-026
- Conditions
- Focal Segmental Glomerulosclerosis
- Keywords
- steroid resistant focal segmental glomerulosclerosis, FSGS, adolescent focal segmental glomerulosclerosis, focal segmental glomerulosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- Apr 2008 (actual)
- Primary completion
- 18 Jun 2009 (actual)
- Study completion
- 18 Jun 2009 (actual)
- First posted
- 31 Oct 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 FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FG-3019 | Experimental | Drug: FG-3019FG-3019 5 mg/kg |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
- Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
- Age less than or equal to 2 years old at onset of proteinuria
- First morning urine protein/creatinine ratio (U p/c) >1 gm/gm
- Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2
Key exclusion criteria (7 listed)
- Non-FSGS renal disease other than benign cyst; or secondary FSGS
- History of organ transplantation
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
- History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
- Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
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-3019FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks | Drug | FG-3019 |
Primary outcome
Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications
Time frame: 32 weeks
2 secondary outcomes
Standard plasma and urinary PK parameters
Time frame: 32 weeks
Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids
Time frame: 8 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
3 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 Focal Segmental Glomerulosclerosis, run by Kyntra Bio at 3 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 5 inclusion and 7 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 was stopped early. 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?
Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications (time frame: 32 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 31 Jul 2019.