Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000697088
Ethics application status
Approved
Date submitted
18/08/2010
Date registered
24/08/2010
Date last updated
24/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ciclosporine Azathioprine versus Tacrolimus mycophenolate mofetil in renal transplantation
Scientific title
A randomized prospective open trial comparing cyclosporine/azathioprine versus tacrolimus/mycophenolate mofetil , associated to rabbit anti-thymocyte globulines (rATG) induction and prednisone in kidney transplantation
Secondary ID [1] 992 0
CRG020600037 (Cochrane Renal Group - CRG)
Universal Trial Number (UTN)
U1111-1116-6101
Trial acronym
CATM2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
renal transplantation 243653 0
Immunosuppressive treatment in renal transplantation 257969 0
Acute rejection and transplant survival in renal transplantation 257984 0
Condition category
Condition code
Renal and Urogenital 258137 258137 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tacrolimus 0.075 mg/Kg/twice daily oral tablet & mycophenolate mofetil 1000 mg/twice daily oral tablet. The duration of the two treatments is prolonged during all the graft survival duration.
Intervention code [1] 257024 0
Treatment: Drugs
Comparator / control treatment
Ciclosporine 6 mg/kgTwice daily, oral tablet & azathioprine 3 mg/Kg/day, once daily, oral tablet. The duration of the two treatments is prolonged during all the graft survival duration.
Control group
Active

Outcomes
Primary outcome [1] 240731 0
Clinical acute rejection during the first year, assessed by an unexplained 20% increase of serum creatinine. All clinical rejections indicate a transplant biopsy.
Timepoint [1] 240731 0
1 year after the graft.
Secondary outcome [1] 257387 0
patient survival assessed by the clinical confirmation that the patient is alive
Timepoint [1] 257387 0
1 year and 3 year after the graft
Secondary outcome [2] 265226 0
kidney survival assessed by the clinical confirmation that the patient is not treated by dyalisis and alive
Timepoint [2] 265226 0
1 year and 3 year after the graft
Secondary outcome [3] 265227 0
kidney function by evaluated Glomerular filtration rate (eGFR) evaluated by Modification of the Diet in Renal Disease simplified formula (MDRD) using creatinine blood level
Timepoint [3] 265227 0
1 year and 3 year after graft
Secondary outcome [4] 265229 0
diabetes assessed by glucose blood level and/or the need of diabetes treatment.
Timepoint [4] 265229 0
1 year and 3 year after the graft

Eligibility
Key inclusion criteria
patient with chronic renal failure indicating a renal transplantation
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
recipient hepatitis B surface antigen positive
older 65 years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation when the kidney graft is proposed to the patient, using a sealed opaque envelopes, without blind, after writed consent
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer randomisation realized before the trial start.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2003 0
France
State/province [1] 2003 0
bouches du rhone

Funding & Sponsors
Funding source category [1] 243597 0
Hospital
Name [1] 243597 0
Assistance publique des Hopitaux de Marseille
Country [1] 243597 0
France
Primary sponsor type
Hospital
Name
Assistance publique des Hopitaux de Marseille
Address
Centre de Nephrologie et Transplantation renale, Hopital de la Conception, AP-HM, 147 Bd Baille, 13005 Marseille, FRANCE
Country
France
Secondary sponsor category [1] 256701 0
None
Name [1] 256701 0
Address [1] 256701 0
Country [1] 256701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259510 0
Comite de Protection des Personnes Sud-Mediterranee II.
Ethics committee address [1] 259510 0
CPP Sud-Mediterranee II - Hopital Salvator - 249 Boulevard Sainte Marguerite 13274 MARSEILLE cx 09
Ethics committee country [1] 259510 0
France
Date submitted for ethics approval [1] 259510 0
Approval date [1] 259510 0
Ethics approval number [1] 259510 0

Summary
Brief summary
Randomized and open monocentral trial evaluating 2 immunosupressive regiments in prevention of acute rejection in renal transplantation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30141 0
Address 30141 0
Country 30141 0
Phone 30141 0
Fax 30141 0
Email 30141 0
Contact person for public queries
Name 13388 0
Dr, Henri, Vacher-Coponat
Address 13388 0
Medical Doctor, Service de Nephrologie, Hopital Conception, Assistance publique des Hopitaux de Marseille, 147 Bd Baille 13005 Marseille , France
Country 13388 0
France
Phone 13388 0
+33 4 91 38 30 42
Fax 13388 0
Email 13388 0
[email protected]
Contact person for scientific queries
Name 4316 0
Dr, Henri, Vacher-Coponat
Address 4316 0
Medical Doctor, Service de Nephrologie, Hopital Conception, Assistance publique des Hopitaux de Marseille, 147 Bd Baille 13005 Marseille , France
Country 4316 0
France
Phone 4316 0
+33 4 91 38 30 42
Fax 4316 0
Email 4316 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.