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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
July 6, 2010
July 9, 2010
March 14, 2017
April 1, 2010
October 30, 2016   (Final data collection date for primary outcome measure)
estimated GFR (MDRD equation)12 months after randomization [ Time Frame: 12 months after randomization ]
estimated GFR (abbreviated MDRD equation)12 months after randomization [ Time Frame: 12 months after randomization ]
Complete list of historical versions of study NCT01159080 on ClinicalTrials.gov Archive Site
  • 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
  • 12 month creatinine clearance (24 hour urine) [ Time Frame: 12 months after randomization ]
    24hr urine collection
  • graft survival [ Time Frame: 12 month after randomization ]
    12 month graft survival
Not Provided
Not Provided
 
Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study

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)
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • 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
  • 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
  • Active Comparator: routine dose tacrolimus and less myfortic
    Intervention: Drug: routine dose tacrolimus and less myfortic
  • Experimental: reduced dose tacrolimus and conventional myfortic
    Intervention: Drug: reduced dose tacrolimus and conventional myfortic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
November 30, 2016
October 30, 2016   (Final data collection date for primary outcome measure)

<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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01159080
CERL080AKR07T
CERL080AKR07T ( Other Grant/Funding Number: NORVATIS )
No
Not Provided
Not Provided
Su-Kil Park, Asan Medical Center
Asan Medical Center
  • Seoul National University Hospital
  • Samsung Medical Center
Principal Investigator: Su-Kil Park, MD,PhD Asan Medical Center
Asan Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP