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OpenTrials
Completed

NCT Number: NCT00098735

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

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.

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Key information

Conditions

Kidney Transplantation Behavior Rejection, Psychology Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FTY720

Drug

Primary outcomes

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

  2. Permanent resumption of dialysis within 6 months post transplant

  3. Surgical removal of graft within 6 months post transplant

  4. Death within 6 months post transplant

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

Secondary outcomes

  1. IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant

  2. Permanent resumption of dialysis within 12 months post transplant

  3. Surgical removal of graft within 12 months post transplant

  4. Death within 12 months post transplant

  5. Withdrawal of consent, death, or lost to follow up within 12 months post transplant

  6. 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.

  7. FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12

  8. Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
First posted
Dec 8, 2004
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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