NCT01817322

Kidney Graft Function Under the Immunosuppression Strategies

Kidney Graft Function Under the Immunosuppression Strategies With Low Dose of Neoral®(Cyclosporine) and Standard Dose of Myfortic®(Enteric-Coated Mycophenolate Sodium) vs. With Conventional Dose of Neoral®(Cyclosporine) and Reduced Dose of Myfortic®(Enteric-Coated Mycophenolate Sodium) in De Novo Renal Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation without an increase of incidences of adverse events, such as biopsy confirmed acute rejection, local or systemic infections, and bone marrow suppression.

Detailed description

This clinical investigation will be the open-label, prospective, multi-center, 1:1 randomized comparative, longitudinal, and investigator-initiated study. Patients with end-stage renal disease will be assessed for the eligibility, and then be randomized using random number table into one of two groups prior to kidney transplantation. Immunosuppression consisted of Cyclosporine(Neoral®), Methylprednisolone OR prednisone OR deflazacort(Brand name is not designated) and Enteric-Coated Mycophenolate Sodium(Myfortic®). Basilixumab(Simulect®) will be given just prior to transplant and 4 days after transplantation. The Enteric-Coated Mycophenolate Sodium will be given orally at the dose of 720 mg BID for Group A (investigational) or 360 mg BID for Group B (comparator), starting at two days after transplantation, as shown in the figure below. Cyclosporine will be given orally at a dose of 10 mg/Kg/day starting at a day before transplantation. Within a month after transplantation, the dose of the drug will be individually adjusted with goal trough blood level between 100 ng/mL and 200 ng/mL for Group A or between 200 ng/mL and 300 ng/mL for Group B, as displayed in the table below. From a month to 2 months post-transplantation, the target blood trough levels of cyclosporine will be reduced to between 75 ng/mL and 150 ng/mL for Group A or between 150 ng/mL and 250 ng/mL for Group B. From 2 months to 4 months post-transplantation, it will be further reduced to between 50 ng/mL and 125 ng/mL for Group A or between 125 ng/mL and 200 ng/mL for Group B. After 4 months post-transplantation, it will be further reduced to between 50 ng/mL and 100 ng/mL for Group A or between 100 ng/mL and 200 ng/mL for Group B.

Conditions

• Chronic Renal Disease

Interventions

Type	Name	Description
DRUG	Standard Dose of Myfortic and Reduced Dose of Myfortic	Low Dose of Neoral (Cyclosporine) and Standard Dose of Myfortic (Enteric-Coated Mycophenolate Sodium) vs. with Conventional Dose of Neoral (Cyclosporine) and Reduced Dose of Myfortic (Enteric-Coated Mycophenolate Sodium)
DRUG	Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental group	500 mg IV Injection in OP Day and 250 mg IV injection in POD1(1 Post op day). And then the drug dose is gradually reduced following the study institution's protocol. But the subject must be take the dose of 5mg of the drug per one day. The drug dose should be controlled on the basis of 5mg of Prednisolone. It can be used with the same dose of methylprednisolone 4 mg or deflazacort 6 mg.
DRUG	Basiliximab injected both control group and experimental group	The subject must be injected 20 mg of Simulect in Kidney transplantation day and just before the OP. After 4 days(96hour ± 12hr), the subject must be injected 20mg of Simulect, again.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-03-25
• Last updated: 2014-10-03