Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CFTY720 0125 | Other Identifier | Sponsor | |
| CFTY7200125 | Other Identifier | Sponsor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, | Experimental |
| |
| FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids | Experimental |
| |
| MMF 2 g + full-dose Neoral (FDN) + corticosteroids | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids | Drug | FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85054 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17198261 | Derived | 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. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FTY720 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) + corticosteroids | Drug | mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids |
|
| 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 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Palo Alto | California | 94303 | United States |
| San Francisco | California | 94143 | United States |
| Denver | Colorado | 80262 | United States |
| New Haven | Connecticut | 06520 | United States |
| Tampa | Florida | 33606 | United States |
| Atlanta | Georgia | 30309 | United States |
| Atlanta | Georgia | 30322 | United States |
| Augusta | Georgia | 30912 | United States |
| Chicago | Illinois | 60612 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Des Moines | Iowa | 50309 | United States |
| Portland | Maine | 04102 | United States |
| Boston | Massachusetts | 02111 | United States |
| Boston | Massachusetts | 02215 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Detroit | Michigan | 48202 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Rochester | Minnesota | 55905 | United States |
| Omaha | Nebraska | 68198 | United States |
| Livingston | New Jersey | 07039 | United States |
| Hawthorne | New York | 10523 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Durham | North Carolina | 27710 | United States |
| Cleveland | Ohio | 44106 | United States |
| Cleveland | Ohio | 44195 | United States |
| Toledo | Ohio | 43614 | United States |
| Portland | Oregon | 97232 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Charleston | South Carolina | 29425 | United States |
| Memphis | Tennessee | 38103 | United States |
| Nashville | Tennessee | 37212 | United States |
| Dallas | Texas | 75246 | United States |
| Galveston | Texas | 77555 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Fairfax | Virginia | 22042 | United States |
| Richmond | Virginia | 23298 | United States |
| Madison | Wisconsin | 53792 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided