Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

Novartis

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Enteric coated mycophenolate sodium (Myfortic®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434590

CERL080AIT09

Details and patient eligibility

About

The study will evaluate kidney graft function in maintenance renal transplant patients.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
• Age > 18 yrs
• Adequate and stable renal function
• Informed consent.

Exclusion criteria

• Kidney transplant combined with other organs;
• Significant proteinuria
• Severe ongoing infections;
• Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
• Relapse of the end-stage renal disease on the transplanted kidney;
• Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Full Dose Myfortic® and Reduced Dose Neoral®

Experimental group

Description:

The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME

Treatment:

Drug: Enteric coated mycophenolate sodium (Myfortic®)

Standard Dose of Myfortic® and Standard Dose of CsA-ME

Active Comparator group

Description:

Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.

Treatment:

Drug: Enteric coated mycophenolate sodium (Myfortic®)