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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159080
First Posted: July 9, 2010
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Seoul National University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
Su-Kil Park, Asan Medical Center
  Purpose

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)

Condition Intervention Phase
Kidney Transplantation Drug: routine dose tacrolimus and less myfortic Drug: reduced dose tacrolimus and conventional myfortic Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Su-Kil Park, Asan Medical Center:

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

Secondary Outcome Measures:
  • Urine protein excretion [ Time Frame: 12 months after randomization ]
    24hr urine collection or urine protein/creatinine ratio

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

  • follow-up loss [ Time Frame: From randomization to 12 months after randomization ]
    frequency of follow-up loss

  • Allograft biopsy [ Time Frame: From randomization to 12 months after randomization ]
    number of performed allograft biopsy performed

  • Treated or biopsy proven acute rejection [ Time Frame: From randomization to 12 months after randomization ]
  • estimated GFR change from randomization to end of the study [ Time Frame: 12 months after randomization ]
    calculated by MDRD equation and Nankivell equation


Enrollment: 350
Actual Study Start Date: April 1, 2010
Study Completion Date: November 30, 2016
Primary Completion Date: October 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: routine dose tacrolimus and less myfortic Drug: routine dose tacrolimus and less myfortic
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
Experimental: reduced dose tacrolimus and conventional myfortic Drug: reduced dose tacrolimus and conventional myfortic
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

  Eligibility

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159080


Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01159080     History of Changes
Other Study ID Numbers: CERL080AKR07T
CERL080AKR07T ( Other Grant/Funding Number: NORVATIS )
First Submitted: July 6, 2010
First Posted: July 9, 2010
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Su-Kil Park, Asan Medical Center:
immunosuppression control in kidney transplantation

Additional relevant MeSH terms:
Tacrolimus
Calcineurin Inhibitors
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents