Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.