Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients

Phase 3

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Enteric-coated mycophenolate sodium (EC-MPS); Drug: Prednisone

• Registration Number: NCT00413920
• Lead Sponsor: Novartis

Brief Summary

This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Study Start: 2007-04
• Primary Completion: 2009-03
• Results First Submitted: 2011-01-12
• Results First Submitted QC: 2011-01-12
• Results First Posted: 2011-02-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-19
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• Primary donor kidney transplant
• Panel reactive antibody (PRA) ≤ 20%

Exclusion Criteria

• Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
• Non-heart beating donor or kidney from a non-compatible donor

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Steroids	Enteric-coated mycophenolate sodium (EC-MPS)	Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
With Steroids	Enteric-coated mycophenolate sodium (EC-MPS)	Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
With Steroids	Prednisone	Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation	6 months post transplantation	Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.

Secondary Outcome Measures

Name	Time	Method
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months	Month 6	If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months	Month 3	A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
Number of Participants With Subclinical Histological Rejections	Month 3	The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.
Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status	Month 3	The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.; Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.; Slow graft function is defined as a serum creatinine value \> 250 µmol/L at day 5.
Number of Participants Requiring Steroids in Non-steroid Treatment Group	Months 3 and 6

Trial Locations

Locations (1)

C.H.U. La Milétrie; 🇫🇷 Poitiers, France