Efficacy of Certican® in Combination With Myfortic® in Renal

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic® plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate (cGFR) from baseline to month 12.

The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.

Patients will be submitted to monthly GFR determination but, for group comparison, only the GFR measured at month 12 and month 24 of renal transplantation will be used.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Universitário São José
• Treatments: Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Men and women between 18-70 years old

• Receptors of a first living-donor kidney allograft

• Patients must have been on a tacrolimus+myfortic regimen for at least 2 weeks prior to randomization

Exclusion Criteria:

• Patients with evidence of any acute rejection following transplantation at the time of randomization

• GFR ≤ 35 ml/min

• Proteinuria > 800 mg/day

• Recipients of multiple organ transplants

• Chronic hepatic failure

• Asymptomatic bacteriuria

• Creatinine ≥ 2mg/dL on CNI withdrawn time

• Proteinuria ≥ 1g/24h on CNI withdrawn time

• Presence of uncontrolled hypercholesterolemia (≥ 350 mg/dL, ≥ 9.1 mmol/L)

• Hypertriglyceridemia (≥ 500 mg/dL, ≥ 5.6 mmol/L)