Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000070033
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
6/03/2006
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized trial to compare efficacy and safety of cyclosporin-prednisone versus mycophenolate mofetil-prednisone, 3 months after renal transplantation.
Scientific title
A randomized trial to compare efficacy and safety of cyclosporin-prednisone versus mycophenolate mofetil-prednisone, 3 months after renal transplantation.
Secondary ID [1] 1010 0
Cochrane Renal Group 030600045
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal transplantation 243726 0
Condition category
Condition code
Renal and Urogenital 256695 256695 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
mycophenolate mofetil 2g per day and prednisone 0.15 mg/kg, per day from month 3 to 12 post graft. Both drugs: oral capsules
Intervention code [1] 255804 0
Treatment: Drugs
Comparator / control treatment
cyclosporine 3-8 mg/kg per day adjusted for blood trough levels between 100 and 300 mcg/L and prednisone 0.15 mg/kg per day from month 3 to 12 post graft. Both drugs: oral capsules
Control group
Active

Outcomes
Primary outcome [1] 257585 0
Incidence of biopsy-proven acute allograft rejection during the first post-transplant year
Timepoint [1] 257585 0
12 months post transplant
Secondary outcome [1] 262838 0
Serum creatinine
Timepoint [1] 262838 0
12 months post transplant (once monthly from month 3 to 12 post graft)
Secondary outcome [2] 262839 0
graft and patient survival (the date of the graft failure was defined as the day when dialysis was restarted or patient death)
Timepoint [2] 262839 0
12 months post transplant
Secondary outcome [3] 262840 0
Chronic Allograft Dysfunction Index (CADI)
Timepoint [3] 262840 0
12 months post transplant (comparison of 2 timepoints biopsies, at 3 and 12 months post graft respectively)

Eligibility
Key inclusion criteria
1) First renal transplantation from a deceased donor under a triple drug regimen (cyclosporine + mycophenolate mofetil + prednisone)

2) No acute rejection episode during the first 3 months post graft (time of randomisation)

3) Patients who gave their informed consent and are able to understand the scope of the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Living donor, re-transplantation

2) Panel ractive antibodies > 30%

3) Serum creatinine > 2.5 mg/dl (222 umol/l)

4) Cyclosporine toxicity at the time of randomisation (3 months post graft)

5) Patients with generalized infection at the time of transplantation

6) Women in child-bearing age who do not plan to use efficient contraception

7) Age of donor > 65

Study design
Purpose of the study
Treatment
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment outside Australia
Country [1] 2047 0
France
State/province [1] 2047 0

Funding & Sponsors
Funding source category [1] 256289 0
Government body
Name [1] 256289 0
Protocole Hospitalier de Recherche Clinique (PHRC)
Country [1] 256289 0
France
Primary sponsor type
Government body
Name
Protocole Hospitalier de Recherche Clinique (PHRC)
Address
French Minister of Health

Ministere de la Sante et des Sports
14, avenue Duquesne
75350 PARIS 07 SP
Country
France
Secondary sponsor category [1] 251614 0
Other Collaborative groups
Name [1] 251614 0
Santelys Association
Address [1] 251614 0
Santelys - Parc Eurasante - 351 rue Ambroise Pare - 59120 LOOS - FRANCE
Country [1] 251614 0
France

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this study was to compare the incidence of acute rejection in de novo low risk renal transplant patients after an early cyclosporin or mycophenolate mofetil withdrawal (3 months post graft) from an initial triple drug regimen (cyclosporin + mycophenolate + prednisone).
The primary outcome was the incidence of biopsy proven acute rejection (BPAR) episodes at 12 months post graft.
We tested the hypothesis of a unilateral equivalence of an incidence of 10% BPAR in the cyclosporin group. With a non inferiority limit of 15% the number of patients to include was 98. To take into account a 10% rate of non assessable patients for the statistical analysis, 108 patients were enrolled (54 in each group).
Trial website
Trial related presentations / publications
Predictive factors of acute rejection after early cyclosporine withdrawal in renal transplant recipients who receive mycophenolate mofetil: results from a prospective, randomized trial. M Hazzan, M Labalette, MC Copin, F Glowacki, F Provot, FR Pruvot, C Noel. J Am Soc Nephrol. 2005 ; 16 : 2509-2516
Assessment of the risk of chronic allograft dysfunction after renal transplantation in a randomized cyclosporine withdrawal trial. M Hazzan, D Buob, M Labalette, F Provot, F Glowacki, M Hoffmann, MC Copin, C Noël. Transplantation. 2006 ; 15 : 657-662
Public notes

Contacts
Principal investigator
Name 30179 0
Address 30179 0
Country 30179 0
Phone 30179 0
Fax 30179 0
Email 30179 0
Contact person for public queries
Name 13426 0
Prof, Christian, NOEL
Address 13426 0
Head, Nephrology, Regional Hospital of Lille, Hopital Huriez, CHRU de Lille. 59037 Lille cedex (France)
Country 13426 0
France
Phone 13426 0
+33 3 20 44 41 42
Fax 13426 0
Email 13426 0
[email protected]
Contact person for scientific queries
Name 4354 0
Prof, Marc, HAZZAN
Address 4354 0
Nephrology, Regional Hospital of Lille, Hopital Huriez, CHRU de Lille. 59037 Lille cedex (France)
Country 4354 0
France
Phone 4354 0
+33 3 20 44 67 70
Fax 4354 0
Email 4354 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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