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

NCT00413920 | Completed Phase 3 Results

• 1 other identifier: CERL080AFR05
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplantation

Keywords

Steroids avoidance,; enteric-coated mycophenolate sodium (EC-MPS),; de novo renal transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Occurrence of Treatment Failures at 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.

  6 months post transplantation

Secondary Outcomes (5)

• The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months

  Month 6

• Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months

  Month 3

• Number of Participants With Subclinical Histological Rejections

  Month 3

• Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status

  Month 3

• Number of Participants Requiring Steroids in Non-steroid Treatment Group

  Months 3 and 6

Study Arms (2)

Without Steroids

EXPERIMENTAL

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.

Drug: Enteric-coated mycophenolate sodium (EC-MPS)

With Steroids

ACTIVE COMPARATOR

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.

Drug: Enteric-coated mycophenolate sodium (EC-MPS); Drug: Prednisone

Interventions

Enteric-coated mycophenolate sodium (EC-MPS) DRUG

An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.

Also known as: Myfortic

With Steroids; Without Steroids

Prednisone DRUG

Oral tablets

With Steroids

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

C.H.U. La Milétrie

Poitiers, France

Location

MeSH Terms

Interventions

Mycophenolic Acid; Prednisone

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Study Start: April 1, 2007
• Primary Completion: March 1, 2009
• Last Updated: April 21, 2011
• Results First Posted: February 7, 2011

Record last verified: 2011-04

Locations

FR (1)