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

Completed

• Conditions: Renal and Urogenital - Kidney disease; Renal transplantation

• Registration Number: ACTRN12610000070033
• Lead Sponsor: Protocole Hospitalier de Recherche Clinique (PHRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum creatinine[12 months post transplant (once monthly from month 3 to 12 post graft)];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];Chronic Allograft Dysfunction Index (CADI)[12 months post transplant (comparison of 2 timepoints biopsies, at 3 and 12 months post graft respectively)]