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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Brief Summary

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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

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Conditions

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Kidney Transplantation

Keywords

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Kidney,Transplantation, rejection, immunosuppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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FTY720

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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NOVARTIS

Role: STUDY_DIRECTOR

Novartis

Countries

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Belgium Germany Ireland Netherlands Poland United Kingdom United States

References

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Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. Transplantation. 2005 Jun 15;79(11):1553-60.

Reference Type RESULT

PMID: 15940045 (View on PubMed)

Other Identifiers

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CFTY720A2302

Identifier Type: -

Identifier Source: org_study_id