Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsi… (NCT00537862) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
South Korea200 participantsStarted 2006-05
Plain-language summary
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Korean Males and females aged 18 to 65 years.
* Recipients of first, living unrelated or living related non-HLA identical donor kidney
* Transplant, treated with cyclosporine microemulsion (Cs-ME) as primary immunosuppressant.
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication but at least for four months after randomization, even where there has been a history of infertility.
Exclusion Criteria:
* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
* Kidneys from cadaveric donors or HLA identical living related donors.
* Patients with any known hypersensitivity to enteric coated Mycophenolate sodium (EC-MPS) or other components of the formulation (e.g. lactose).
* Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \<1,500/mm3, and/or leukocytopenia (\<4,000/mm3 ), or hemoglobin \< 6g/dL .
* Patients who have received any investigational drug within 30 days prior to study entry.
* Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use …
What they're measuring
1
Efficacy & safety of enteric-coated mycophenolate sodium combined with cyclosporine microemulsion & corticosteroids assessed by overall survival at 6 months, biopsy proven acute rejection, graft loss, adverse events and serious adverse events.