Kidney TransplantationPhase 2/3NCT00099749
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
A Phase 2/3 study testing FTY 720 in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- FTY 720
- How many people
- 255 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2003to Apr 2006
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male and Female
- Between 18 to 65 years old
Who cannot join
- Patients in need of multiple organ transplants
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Barnabas Medical Center
Livingston, New Jersey, 07039
Loyola University Medical Center
Maywood, Illinois, 60153
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital
Providence, Rhode Island, 02903
SIU School of Medicine
Springfield, Illinois, 62781
About this study
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Conditions
- Kidney Transplantation
- Being tested
- FTY 720
- Keywords
- Kidney, immunosuppression, transplant, rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTY 720Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
Secondary outcomes (3)
Safety/tolerability based on adverse event reporting.
BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2004 (estimated)
- Study startNov 2003
- Primary completionApr 2006
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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 255 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099749
- Sponsor's protocol ID
- CFTY720A2218
- Status last verified
- Feb 2017
- First submitted
- 17 Dec 2004
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92. doi: 10.1097/01.tp.0000281385.26500.3b.
PubMed 17984842
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
- ClinicalTrials.gov ID
- NCT00099749
- Acronym / sponsor ID
- CFTY720A2218
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, immunosuppression, transplant, rejection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Apr 2006 (actual)
- First posted
- 20 Dec 2004 (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 efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and Female
- Between 18 to 65 years old
Key exclusion criteria (1 listed)
- Patients in need of multiple organ transplants
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 |
|---|---|---|
| FTY 720 | Drug | – |
Primary outcome
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
3 secondary outcomes
Safety/tolerability based on adverse event reporting.
BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
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 23 Feb 2017.
- Results publication: PubMed 17984842Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92. doi: 10.1097/01.tp.0000281385.26500.3b.
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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.
Novartis study director
Novartis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FTY 720 in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 5 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 1 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.. 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 NCT00099749, 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 23 Feb 2017.