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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098735
• Other study ID #: CFTY720A2302
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2004
• Last updated: November 16, 2016
• Start date: April 2004

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• FTY720

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

References & Publications (1)

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 transplantatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant
Primary	Permanent resumption of dialysis within 6 months post transplant
Primary	Surgical removal of graft within 6 months post transplant
Primary	Death within 6 months post transplant
Primary	Withdrawal of consent, death, or lost to follow up within 6 months post transplant
Secondary	IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
Secondary	Permanent resumption of dialysis within 12 months post transplant
Secondary	Surgical removal of graft within 12 months post transplant
Secondary	Death within 12 months post transplant
Secondary	Withdrawal of consent, death, or lost to follow up within 12 months post transplant
Secondary	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.
Secondary	FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12
Secondary	Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.

External Links

•   Results for CFTY720A2302 from the Novartis Clinical Trials Website