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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Asan Medical Center.
Recruitment status was:  Recruiting
Seoul National University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
Su-Kil Park, Asan Medical Center Identifier:
First received: July 6, 2010
Last updated: January 12, 2015
Last verified: January 2015
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:estimated GFR (abbreviated MDRD equation) 12 months after randomization

Condition Intervention Phase
Kidney Transplantation
Drug: routine dose tacrolimus and myfortic
Drug: low dose tacrolimus and myfortic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • estimated GFR (abbreviated MDRD equation)12 months after randomization [ Time Frame: 12months after randomization ]

Secondary Outcome Measures:
  • 12 month creatinine clearance (24 hour urine) [ Time Frame: 12 months after randomization ]
    24hr urine collection

  • graft survival [ Time Frame: 12month after randomization ]
    12 month graft survival

Estimated Enrollment: 350
Study Start Date: July 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: routine dose tacrolimus and myfortic Drug: routine dose tacrolimus and myfortic
oral regular dose of tacrolimus + usual dose of myfortic trough level of tacrolimus will be 2-5 pg/mL and oral myfortic dose will be 360mg b.i.d.
Other Name: optimum
Experimental: low dose tacrolimus and myfortic Drug: low dose tacrolimus and myfortic
low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-4 pg/mL for 3 months after randomization and oral MPS dose increased to 720mg b.i.d.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • One to five years after a kidney transplant subjects
  • Subject who is using CNI ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
  • serum creatinine < 2 mg/dL and the variation of serum creatinine < 30% during the past 3 months
  • Proteinuria ≤ 1g quantified by 24 hour urine or spot urine protein/creatinine ratio <1.0
  • Subjects who agree with written informed consent

Exclusion Criteria:

  • Subjects who received combined non-renal transplantation.
  • Subject who received re-transplantation
  • deceased donor without a heartbeat
  • Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients.
  • Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferase) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.
  • HLA-identical living related donor
  • ABO blood group incompatible
  • HIV, HBsAg, or HCV Ab tests (+)
  • Abnormal liver function test (AST or ALT or total bilirubin> upper normal limit x3) ANC <1,500/μL or WBC <2,500/μL or platelet <750,000/μL
  • Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.
  • Subjects with history of cancer, except successfully treated, localized nonmelanocytic skin cancer Subjects with clinically significant infections within the past 3 months.
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Please refer to this study by its identifier: NCT01159080

Korea, Republic of
Asan Medical Center
Seoul, Asan Medical Center, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Seoul National University Hospital
Samsung Medical Center
Principal Investigator: Su-Kil Park, MD,PhD Asan Medical Center
  More Information

Responsible Party: Su-Kil Park, Professor, Department of medicine, ASAN Medical CENTER, Asan Medical Center Identifier: NCT01159080     History of Changes
Other Study ID Numbers: CERL080AKR07T  CERL080AKR07T 
Study First Received: July 6, 2010
Last Updated: January 12, 2015

Keywords provided by Asan Medical Center:
immunosuppression control in kidney transplantation

Additional relevant MeSH terms:
Mycophenolate mofetil
Calcineurin Inhibitors
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on February 20, 2017