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

Phase 3

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00098735
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-12-07
• Study First Submitted QC: 2004-12-07
• Study First Posted: 2004-12-08
• Primary Completion: 2006-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

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Exclusion Criteria

• Patient in need of multi-organ transplant
• Patients with history of cardiac arrest
• Patients with any past or present malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Death 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 Outcome Measures

Name	Time	Method
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.
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
Surgical removal of graft within 12 months post transplant