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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00369382




Registration number
NCT00369382
Ethics application status
Date submitted
25/08/2006
Date registered
29/08/2006
Date last updated
30/05/2011

Titles & IDs
Public title
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Scientific 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
Secondary ID [1] 0 0
B1741006
Secondary ID [2] 0 0
0468E7-408
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft Rejection 0 0
Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclosporine or tacrolimus
Treatment: Drugs - sirolimus

Active comparator: 1 - Group 1: Continuation of CNI regimen

Experimental: 2 - Group 2: (CNI-Free) Conversion to SRL-based regimen


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
Timepoint [1] 0 0
Baseline and Week 52
Primary outcome [2] 0 0
Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline
Timepoint [2] 0 0
Baseline
Secondary outcome [1] 0 0
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization
Timepoint [1] 0 0
Baseline and Weeks 4, 16, 24, 32, and 40
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline and Weeks 4, 16, 24, 32, 40 and 52
Secondary outcome [3] 0 0
Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization
Timepoint [4] 0 0
Baseline and Weeks 4, 16, 24, 32, 40, and 52
Secondary outcome [5] 0 0
Serum Creatinine Level at Baseline
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)
Timepoint [6] 0 0
Baseline to discontinuation (up to Week 52)
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Baseline until death (up to Week 56)
Secondary outcome [8] 0 0
Number of Participants With Acute Rejection
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Number of Participants With Biopsy-confirmed Acute Rejection by Severity
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
Time to First Acute Rejection
Timepoint [10] 0 0
Baseline to Week 52
Secondary outcome [11] 0 0
Number of Participants Requiring Antibody Use in Treatment of Acute Rejection
Timepoint [11] 0 0
Baseline to Week 52
Secondary outcome [12] 0 0
Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy
Timepoint [12] 0 0
Baseline up to Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Cantabria
Country [12] 0 0
Spain
State/province [12] 0 0
La Coru?a
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 0 0
Sevilla
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia
Country [16] 0 0
Switzerland
State/province [16] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00369382
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00369382