NCT00903188

Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events. The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

Detailed description

Methodology: * A 5-year, multicentre, prospective, randomized, open-label, controlled study * Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months * Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance. * In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection. Sample size calculations: A total of 152 patients will be randomized (76 patients per group) Population: De novo kidney transplant recipients. Study duration: 1.5 years inclusion+ follow-up during the first 5 years

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	cyclosporine	Cyclosporine (Group 1): basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4 Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml. C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day. Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV. Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop
DRUG	Everolimus	Everolimus (Group 2): Basiliximab dose: idem as in group 1 Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid. Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped. Enteric-coated mycophenolate (MPA) dosing idem as group 1. Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml. Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-04-01
• Completion: 2015-04-01
• First posted: 2009-05-18
• Last updated: 2009-05-18

Locations

5 sites across 1 country: Belgium