Clinical trial NCT01159080: Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
Official title: Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: immunosuppression control in kidney transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Samsung Medical Center
First posted: 2010-07-09
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 endpoints:

1. estimated GFR (MDRD equation) 12 months after randomization
2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)


Eligibility criteria: \<Inclusion criteria\>

1. The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study.
2. Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months
3. Patients with serum creatinine (sCr) level ≤ 2.0 mg/dL and variation of sCr \< 30% for recent 3 months
4. Patients with urine proteinuria/creatinine ratio (PCR) ≤ 1 g/g, or 24 hour urine protein ≤ 1g/day for recent 3 months
5. Patients who provided informed consent.

\<Exclusion criteria\>

1. Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation
2. Patients whose graft from non-heart beating cadaveric donor
3. graft from HLA-identical living related donor
4. ABO blood group incompatible donor or HLA desensitized recipients
5. Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients
6. Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome
7. Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy)
8. Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus
9. 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)
10. Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer
11. Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months
12. Patients who taken medicine from other trial within 30 days.

Primary outcomes:
measure: estimated GFR (MDRD equation)12 months after randomization
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Urine protein excretion
timeFrame: 12 months after randomization
measure: graft survival
timeFrame: 12 month after randomization
measure: follow-up loss
timeFrame: From randomization to 12 months after randomization
measure: Allograft biopsy
timeFrame: From randomization to 12 months after randomization
measure: Treated or biopsy proven acute rejection
timeFrame: From randomization to 12 months after randomization
measure: estimated GFR change from randomization to end of the study
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Su-Kil Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, Kim YH, Kim JK, Oh CK, Park SK. Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study. Ann Transplant. 2018 Jun 12;23:401-411. doi: 10.12659/AOT.909036.