A Phase 3 interventional study of FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids and FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids in Kidney Transplantation, sponsored by Novartis Pharmaceuticals. Completed at 42 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
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
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
Plan to share: 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
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals