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Completed

NCT Number: NCT01159080

Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients

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)

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Key information

Conditions

Kidney Transplantation

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, Asan Medical Center, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<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.

Treatment and study plan

routine dose tacrolimus and less myfortic

Drug

oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day

reduced dose tacrolimus and conventional myfortic

Drug

low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day

Primary outcomes

  1. estimated GFR (MDRD equation)12 months after randomization

    Time frame: 12 months after randomization

Secondary outcomes

  1. Urine protein excretion

    Time frame: 12 months after randomization

    24hr urine collection or urine protein/creatinine ratio

  2. graft survival

    Time frame: 12 month after randomization

    12 month graft survival

  3. follow-up loss

    Time frame: From randomization to 12 months after randomization

    frequency of follow-up loss

  4. Allograft biopsy

    Time frame: From randomization to 12 months after randomization

    number of performed allograft biopsy performed

  5. Treated or biopsy proven acute rejection

    Time frame: From randomization to 12 months after randomization

  6. estimated GFR change from randomization to end of the study

    Time frame: 12 months after randomization

    calculated by MDRD equation and Nankivell equation

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Samsung Medical Center
  • Seoul National University Hospital

Registry information

Official study title

Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study

Acronym: OPTIMUM

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2010
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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