Renal AnemiaPhase 2NCT00456053
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin
A Phase 2 study testing FG2216 in people with Renal Anemia, run by Kyntra Bio at 27 sites in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Anemia
- What is being tested?
- FG2216
- How many people
- 145 participants
- Where
- 27 sitesUnited States
- Study dates
- Dec 2005to Jul 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 3 or 4 chronic kidney disease
- appropriate hemoglobin levels
Who cannot join
- Neovascular age related macular degeneration requiring treatment
- Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
- Any history of malignancy
- Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
- Renal Transplant
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Research Site
Allentown, Pennsylvania
Research Site
Atlanta, Georgia
Research Site
Chesapeake, Virginia
Research Site
Cincinnati, Ohio
Research Site
Columbus, Ohio
Research Site
Fairfax, Virginia
Research Site
Flushing, New York
Research Site
Hershey, Pennsylvania
Research Site
Houston, Texas
Research Site
Kalamazoo, Michigan
Research Site
Lauderdale Lakes, Florida
Research Site
Little Rock, Arkansas
3 Research Sites
Los Angeles, California
Research Site
Miami, Florida
Research Site
Oakland, California
Research Site
Orangeburg, South Carolina
Research Site
Pembroke Pines, Florida
Research Site
Pittsburgh, Pennsylvania
Research Site
Pontiac, Michigan
Research Site
Portland, Oregon
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Santa Clara, California
Research Site
Shreveport, Louisiana
Research Site
South Holland, Illinois
Research Site
Springfield, Massachusetts
Research Site
Tucson, Arizona
About this study
The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.
- Conditions
- Renal Anemia
- Being tested
- FG2216
- Keywords
- Renal Anemia, Renal Failure, Kidney Disease, Human EPO
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG2216Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (Hb) response
Secondary outcomes (3)
Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startDec 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies 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
- Factorial
- Masking
- Single blind
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456053
- Sponsor's protocol ID
- FGCL-SM2216-019
- Status last verified
- Nov 2007
- First submitted
- 2 Apr 2007
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin
- ClinicalTrials.gov ID
- NCT00456053
- Acronym / sponsor ID
- FGCL-SM2216-019
- Conditions
- Renal Anemia
- Keywords
- Renal Anemia, Renal Failure, Kidney Disease, Human EPO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 4 Apr 2007 (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 test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage 3 or 4 chronic kidney disease
- appropriate hemoglobin levels
Key exclusion criteria (5 listed)
- Neovascular age related macular degeneration requiring treatment
- Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
- Any history of malignancy
- Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
- Renal Transplant
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 |
|---|---|---|
| FG2216 | Drug | – |
Primary outcome
Hemoglobin (Hb) response
3 secondary outcomes
Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety
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 6 Nov 2007.
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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.
27 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 FG2216 in people with Renal Anemia, run by Kyntra Bio at 27 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 2 inclusion and 5 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 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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 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?
Hemoglobin (Hb) response. 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 6 Nov 2007.