Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation
Yonsei Medical Journal
;
: 217-225, 2017.
Article
in English
| WPRIM
| ID: wpr-126254
ABSTRACT
PURPOSE:
The increased tolerability of enteric-coated mycophenolate sodium (EC-MPS), compared to mycophenolate mofetil, among kidney transplant recipients has the potential to facilitate cyclosporine (CsA) minimization. Therefore, a prospective trial to determine the optimum EC-MPS dose in CsA-based immunosuppression regimens is necessary. MATERIALS ANDMETHODS:
A comparative, parallel, randomized, open-label study was performed for 140 patients from four centers to compare the efficacy and tolerability of low dose CsA with standard dose EC-MPS (the investigational group) versus standard dose CsA with low dose EC-MPS (the control group) for six months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure [biopsy-confirmed acute rejection (BCAR), death, graft loss, loss to follow-up], and adverse events were compared.RESULTS:
The mean estimated glomerular filtration rate (eGFR) of the investigational group at six months post-transplantation was non-inferior to that of the control group (confidence interval between 57.3 mL/min/1.73m² and 67.4 mL/min/1.73 m², p0.05) in the incidence of discontinuations and serious adverse events (SAE) between the groups.CONCLUSION:
CsA minimization using a standard dose of EC-MPS kept the incidence of acute rejection and additional risks as low as conventional immunosuppression and provided therapeutic equivalence in terms of renal graft function and safety issues.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Tablets, Enteric-Coated
/
Time Factors
/
Incidence
/
Prospective Studies
/
Kidney Transplantation
/
Cyclosporine
/
Graft Rejection
/
Immunosuppressive Agents
/
Mycophenolic Acid
Type of study:
Controlled clinical trial
/
Incidence study
/
Observational study
/
Prognostic study
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
Language:
English
Journal:
Yonsei Medical Journal
Year:
2017
Type:
Article
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