Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

PHASE4CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

April 30, 2010

Study Completion Date

May 31, 2010

Conditions
Graft RejectionKidney Failure
Interventions
DRUG

cyclosporine or tacrolimus

Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.

DRUG

sirolimus

Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.

Trial Locations (23)

1003

Pfizer Investigational Site, Epsom

2010

Pfizer Investigational Site, Darlinghurst

3010

Pfizer Investigational Site, Bern

15001

Pfizer Investigational Site, La Coru?a

15213

Pfizer Investigational Site, Pittsburgh

19102

Pfizer Investigational Site, Philadelphia

19104

Pfizer Investigational Site, Philadelphia

23507

Pfizer Investigational Site, Norfolk

28035

Pfizer Investigational Site, Madrid

33606

Pfizer Investigational Site, Tampa

39008

Pfizer Investigational Site, Santander

41013

Pfizer Investigational Site, Seville

46009

Pfizer Investigational Site, Valencia

55905

Pfizer Investigational Site, Rochester

77030

Pfizer Investigational Site, Houston

10027-6902

Pfizer Investigational Site, New York

A-1090

Pfizer Investigational Site, Vienna

H1T 1C8

Pfizer Investigational Site, Montreal

G1V 4G5

Pfizer Investigational Site, Québec

Pfizer Investigational Site, Sainte-Foy

Unknown

Pfizer Investigational Site, Auckland

08907

Pfizer Investigational Site, L'Hospitalet de Llobregat

08036

Pfizer Investigational Site, Barcelona

All Listed Sponsors
lead

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

NCT00369382 - Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients | Biotech Hunter | Biotech Hunter