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Clinical Trials/NCT00098735
NCT00098735CompletedPhase 3

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

Novartis Pharmaceuticals0 sites140 target enrollmentStarted: April 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
140
Primary Endpoint
Death within 6 months post transplant
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Death within 6 months post transplant

IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant

Surgical removal of graft within 6 months post transplant

Permanent resumption of dialysis within 6 months post transplant

Withdrawal of consent, death, or lost to follow up within 6 months post transplant

Secondary Outcomes

  • 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
  • Permanent resumption of dialysis within 12 months post transplant
  • Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
  • Surgical removal of graft within 12 months post transplant
  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria 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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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