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Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099736
First Posted: December 20, 2004
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
December 17, 2004
December 20, 2004
August 22, 2017
May 7, 2003
September 19, 2005   (Final data collection date for primary outcome measure)
  • 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
To compare the efficacy and safety of FTY720 in kidney transplantation.
Complete list of historical versions of study NCT00099736 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
    FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
  • Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
    FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
  • Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
    mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
  • Experimental: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,
    Intervention: Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
  • Experimental: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
    Intervention: Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
  • Experimental: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
    Intervention: Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
696
September 19, 2005
September 19, 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • First kidney transplantation
  • Male and female patients
  • Between 18 and 65 years old

Exclusion Criteria:

  • Patients in need of multiple organ transplants
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Argentina,   Brazil,   Canada,   Colombia,   France,   Germany,   Italy,   Mexico,   Switzerland
 
NCT00099736
CFTY720A0125
CFTY720 0125 ( Other Identifier: Sponsor )
CFTY7200125 ( Other Identifier: Sponsor )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Plan Description:

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

Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP