Status:
COMPLETED
Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Samsung Medical Center
Conditions:
Kidney Transplantation
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects Primary...
Eligibility Criteria
Inclusion
- \<Inclusion criteria\>
- The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study.
- Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months
- Patients with serum creatinine (sCr) level ≤ 2.0 mg/dL and variation of sCr \< 30% for recent 3 months
- Patients with urine proteinuria/creatinine ratio (PCR) ≤ 1 g/g, or 24 hour urine protein ≤ 1g/day for recent 3 months
- Patients who provided informed consent.
- \<Exclusion criteria\>
- Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation
- Patients whose graft from non-heart beating cadaveric donor
- graft from HLA-identical living related donor
- ABO blood group incompatible donor or HLA desensitized recipients
- Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients
- Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome
- Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy)
- Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus
- Patients with liver function test abnormality (alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> 3 times from upper normal limit), neutropenia (absolute neutrophil count \< 1,500/uL or white blood cell count \< 2,500/uL), or thrombocytopenia (platelet \< 75,000)
- Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer
- Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months
- Patients who taken medicine from other trial within 30 days.
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01159080
Start Date
April 1 2010
End Date
November 30 2016
Last Update
March 14 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, Asan Medical Center, South Korea, 138-736