Kidney TransplantationPhase 3NCT00099736
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
A Phase 3 study testing FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids and MMF 2 g + full-dose Neoral (FDN) + corticosteroids in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 42 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?
- FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids and MMF 2 g + full-dose Neoral (FDN) + corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 696 participants
- Where
- 42 sitesUnited States
- Study dates
- 7 May 2003to 19 Sep 2005
- 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
- Patients in need of multiple organ transplants
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30309
Study site
Atlanta, Georgia, 30322
Study site
Augusta, Georgia, 30912
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02215
Study site
Chapel Hill, North Carolina, 27599
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44106
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75246
Study site
Denver, Colorado, 80262
Study site
Des Moines, Iowa, 50309
Study site
Detroit, Michigan, 48202
Study site
Durham, North Carolina, 27710
Study site
Fairfax, Virginia, 22042
Study site
Galveston, Texas, 77555
Study site
Hawthorne, New York, 10523
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Livingston, New Jersey, 07039
Study site
Los Angeles, California, 90057
Study site
Madison, Wisconsin, 53792
Study site
Memphis, Tennessee, 38103
Study site
Milwaukee, Wisconsin, 53226
Study site
Minneapolis, Minnesota, 55455
Study site
Nashville, Tennessee, 37212
Study site
New Haven, Connecticut, 06520
Study site
Omaha, Nebraska, 68198
Study site
Palo Alto, California, 94303
Study site
Philadelphia, Pennsylvania, 19102
Study site
Phoenix, Arizona, 85054
Study site
Portland, Maine, 04102
Study site
Portland, Oregon, 97232
Study site
Richmond, Virginia, 23298
Study site
Rochester, Minnesota, 55905
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
San Francisco, California, 94143
Study site
Tampa, Florida, 33606
Study site
Toledo, Ohio, 43614
About this study
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Conditions
- Kidney Transplantation
- Being tested
- FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids, MMF 2 g + full-dose Neoral (FDN) + corticosteroids
- 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.
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroidsDrug
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroidsDrug
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
MMF 2 g + full-dose Neoral (FDN) + corticosteroidsDrug
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, | Experimental | Not described Receives: Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids |
| FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids | Experimental | Not described Receives: Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids |
| MMF 2 g + full-dose Neoral (FDN) + corticosteroids | Experimental | Not described Receives: Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids |
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 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
Secondary outcomes (5)
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
serum creatinine
cystatin C at months 3, 6, and 12
proteinuria at day 28, months 6 and 12
absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 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 posted20 Dec 2004 (estimated)
- Study start7 May 2003
- Primary completion19 Sep 2005
- Study completion19 Sep 2005
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 696 participants (actual)
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
- NCT00099736
- Sponsor's protocol ID
- CFTY720A0125
- Other IDs
- CFTY720 0125, CFTY7200125
- Status last verified
- Aug 2017
- First submitted
- 17 Dec 2004
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Tedesco-Silva H, Pescovitz MD, Cibrik D, Rees MA, Mulgaonkar S, Kahan BD, Gugliuzza KK, Rajagopalan PR, Esmeraldo Rde M, Lord H, Salvadori M, Slade JM; FTY720 Study Group. Randomized controlled trial of FTY720 versus MMF in de novo renal transplantation. Transplantation. 2006 Dec 27;82(12):1689-97. doi: 10.1097/01.tp.0000251718.95622.b3.
PubMed 17198261
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. 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 Transplant
- ClinicalTrials.gov ID
- NCT00099736
- Acronym / sponsor ID
- CFTY720A0125
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, transplantation, rejection, immunosuppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 May 2003
- Primary completion
- 19 Sep 2005 (actual)
- Study completion
- 19 Sep 2005 (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 (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, | Experimental | Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids |
| FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids | Experimental | Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids |
| MMF 2 g + full-dose Neoral (FDN) + corticosteroids | Experimental | Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids |
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 (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 |
|---|---|---|
| FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroidsFTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids | Drug | FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, |
| FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroidsFTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids | Drug | FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids |
| MMF 2 g + full-dose Neoral (FDN) + corticosteroidsmycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids | Drug | MMF 2 g + full-dose Neoral (FDN) + corticosteroids |
Primary outcome
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
5 secondary outcomes
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
serum creatinine
cystatin C at months 3, 6, and 12
proteinuria at day 28, months 6 and 12
absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 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 22 Aug 2017.
- Derived from this study: PubMed 17198261Tedesco-Silva H, Pescovitz MD, Cibrik D, Rees MA, Mulgaonkar S, Kahan BD, Gugliuzza KK, Rajagopalan PR, Esmeraldo Rde M, Lord H, Salvadori M, Slade JM; FTY720 Study Group. Randomized controlled trial of FTY720 versus MMF in de novo renal transplantation. Transplantation. 2006 Dec 27;82(12):1689-97. doi: 10.1097/01.tp.0000251718.95622.b3.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids and MMF 2 g + full-dose Neoral (FDN) + corticosteroids in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 42 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 3 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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 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 12 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 NCT00099736, 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 Aug 2017.