A randomized trial to compare efficacy and safety of cyclosporin-prednisone versus mycophenolate mofetil-prednisone, 3 months after renal transplantation.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000070033
• Date of registration: 06/03/2006
• Prospective Registration: No
• Primary sponsor: Protocole Hospitalier de Recherche Clinique (PHRC)
• 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.
• Date of first enrolment: 01/01/1999
• Target sample size: 108
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12610000070033.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;

Countries of recruitment

France

Contacts

• Name: Prof, Marc, HAZZAN

• Name: Prof, Christian, NOEL

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Renal transplantation;
Renal transplantation

Renal and Urogenital - Kidney disease

Intervention(s)

mycophenolate mofetil 2g per day and prednisone 0.15 mg/kg, per day from month 3 to 12 post graft. Both drugs: oral capsules

Primary Outcome(s)

Incidence of biopsy-proven acute allograft rejection during the first post-transplant year[12 months post transplant]

Secondary Outcome(s)

graft and patient survival (the date of the graft failure was defined as the day when dialysis was restarted or patient death)[12 months post transplant]

Serum creatinine[12 months post transplant (once monthly from month 3 to 12 post graft)]

Chronic Allograft Dysfunction Index (CADI)[12 months post transplant (comparison of 2 timepoints biopsies, at 3 and 12 months post graft respectively)]

Secondary ID(s)

Cochrane Renal Group 030600045

Source(s) of Monetary Support

Protocole Hospitalier de Recherche Clinique (PHRC)

Secondary Sponsor(s)

Santelys Association