Overview

Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients

Status:
Completed

Trial end date:
2008-12-01

Target enrollment:

Participant gender:

Summary

This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).

Phase:

Phase 3

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Cyclosporine
Cyclosporins
Mycophenolate mofetil
Mycophenolic Acid