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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00098735
First received: December 7, 2004
Last updated: November 1, 2011
Last verified: November 2011
History of Changes

December 7, 2004
November 1, 2011
April 2004
April 2006   (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 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
To compare efficacy of FTY720 in combination with two other drugs vs. a marketed drug to prevent rejection.
Complete list of historical versions of study NCT00098735 on ClinicalTrials.gov Archive Site
  • 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.
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Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
Drug: FTY720
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
Not Provided
April 2006   (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:

  • Patient in need of multi-organ transplant
  • Patients with history of cardiac arrest
  • Patients with any past or present malignancy
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00098735
CFTY720A2302
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: NOVARTIS Novartis
Novartis
November 2011

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