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

November 16, 2016 updated by: Novartis Pharmaceuticals
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

140

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

December 7, 2004

First Submitted That Met QC Criteria

December 7, 2004

First Posted (Estimate)

December 8, 2004

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720A2302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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