Clinical trial NCT00369382: Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Official title: A Randomized Open-Label Study To Compare The Safety And Efficacy Of Conversion From A Calcineurin Inhibitor To Sirolimus Vs Continued Use Of A Calcineurin Inhibitor In Heart Transplant Recipients With Mild-Moderate Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Graft Rejection
Kidney Failure
Keywords: Heart Transplant
Kidney Failure
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.


Eligibility criteria: Inclusion Criteria:

* Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
* 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion Criteria:

* Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
* Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
* History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.

Primary outcomes:
measure: Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
timeFrame: Baseline and Week 52
measure: Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization
timeFrame: Baseline and Weeks 4, 16, 24, 32, and 40
measure: Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization
timeFrame: Baseline and Weeks 4, 16, 24, 32, 40 and 52
measure: Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline
timeFrame: Baseline
measure: Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization
timeFrame: Baseline and Weeks 4, 16, 24, 32, 40, and 52
measure: Serum Creatinine Level at Baseline
timeFrame: Baseline
measure: Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)
timeFrame: Baseline to discontinuation (up to Week 52)
measure: Overall Survival (OS)
timeFrame: Baseline until death (up to Week 56)
measure: Number of Participants With Acute Rejection
timeFrame: Baseline to Week 52
measure: Number of Participants With Biopsy-confirmed Acute Rejection by Severity
timeFrame: Baseline to Week 52
measure: Time to First Acute Rejection
timeFrame: Baseline to Week 52
measure: Number of Participants Requiring Antibody Use in Treatment of Acute Rejection
timeFrame: Baseline to Week 52
measure: Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Epsom
country: New Zealand
facility: Pfizer Investigational Site
state: Auckland
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: La Coru?a
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zuckermann A, Keogh A, Crespo-Leiro MG, Mancini D, Vilchez FG, Almenar L, Brozena S, Eisen H, Tai SS, Kushwaha S. Randomized controlled trial of sirolimus conversion in cardiac transplant recipients with renal insufficiency. Am J Transplant. 2012 Sep;12(9):2487-97. doi: 10.1111/j.1600-6143.2012.04131.x. Epub 2012 Jul 9.