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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00098735

Enrollment

140

Registered

2004-12-08

Start date

2004-04-30

Completion date

Unknown

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney,Transplantation, rejection, immunosuppression

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.

Interventions

DRUGFTY720

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant	—
Absolute lymphocyte count 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	—
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026