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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Full Dose Myfortic® and Reduced Dose Neoral®

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

Group Type EXPERIMENTAL

Enteric coated mycophenolate sodium (Myfortic®)

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Enteric coated mycophenolate sodium (Myfortic®)

Intervention Type DRUG

Interventions

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Enteric coated mycophenolate sodium (Myfortic®)

Intervention Type DRUG

Other Intervention Names

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Myfortic

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No