Kidney TransplantationPhase 3NCT00098735
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
A Phase 3 study testing FTY720 in people with Kidney Transplantation, run by Novartis Pharmaceuticals.
Trial summary
In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. 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?
- FTY720
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Apr 2006
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First kidney transplantation
- Male and female patients
- Between 18 and 65 years old
Who cannot join
- Patient in need of multi-organ transplant
- Patients with history of cardiac arrest
- Patients with any past or present malignancy
About this study
In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.
- Conditions
- Kidney Transplantation
- Being tested
- FTY720
- Keywords
- Kidney,Transplantation, rejection, immunosuppression
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTY720Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant
Permanent resumption of dialysis within 6 months post transplant
Surgical removal of graft within 6 months post transplant
Death within 6 months post transplant
Withdrawal of consent, death, or lost to follow up within 6 months post transplant
Secondary outcomes (8)
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
Permanent resumption of dialysis within 12 months post transplant
Surgical removal of graft within 12 months post transplant
Death within 12 months post transplant
Withdrawal of consent, death, or lost to follow up within 12 months post transplant
Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12
Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2004 (estimated)
- Study startApr 2004
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 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
- NCT00098735
- Sponsor's protocol ID
- CFTY720A2302
- Status last verified
- Nov 2016
- First submitted
- 7 Dec 2004
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. Transplantation. 2005 Jun 15;79(11):1553-60.
PubMed 15940045
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00098735
- Acronym / sponsor ID
- CFTY720A2302
- Conditions
- Kidney Transplantation
- Keywords
- Kidney,Transplantation, rejection, immunosuppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Apr 2006 (actual)
- First posted
- 8 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.
In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First kidney transplantation
- Male and female patients
- Between 18 and 65 years old
Key exclusion criteria (3 listed)
- Patient in need of multi-organ transplant
- Patients with history of cardiac arrest
- Patients with any past or present malignancy
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 |
|---|---|---|
| FTY720 | Drug | – |
Primary outcome
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant
Permanent resumption of dialysis within 6 months post transplant
Surgical removal of graft within 6 months post transplant
Death within 6 months post transplant
Withdrawal of consent, death, or lost to follow up within 6 months post transplant
8 secondary outcomes
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
Permanent resumption of dialysis within 12 months post transplant
Surgical removal of graft within 12 months post transplant
Death within 12 months post transplant
Withdrawal of consent, death, or lost to follow up within 12 months post transplant
Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12
Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
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 18 Nov 2016.
- Results publication: PubMed 15940045Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. Transplantation. 2005 Jun 15;79(11):1553-60.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FTY720 in people with Kidney Transplantation, run by Novartis Pharmaceuticals.
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 3 inclusion and 3 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant. The study lists 5 primary outcomes in all. 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 NCT00098735, 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 18 Nov 2016.