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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Asan Medical Center
Sponsor:
Collaborators:
Seoul National University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
Su-Kil Park, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01159080
First received: July 6, 2010
Last updated: January 12, 2015
Last verified: January 2015

July 6, 2010
January 12, 2015
July 2010
March 2016   (final data collection date for primary outcome measure)
estimated GFR (abbreviated MDRD equation)12 months after randomization [ Time Frame: 12months after randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01159080 on ClinicalTrials.gov Archive Site
  • 12 month creatinine clearance (24 hour urine) [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
    24hr urine collection
  • graft survival [ Time Frame: 12month after randomization ] [ Designated as safety issue: No ]
    12 month graft survival
Same as current
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:estimated GFR (abbreviated MDRD equation) 12 months after randomization
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • 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
  • 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.
  • Active Comparator: routine dose tacrolimus and myfortic
    Intervention: Drug: routine dose tacrolimus and myfortic
  • Experimental: low dose tacrolimus and myfortic
    Intervention: Drug: low dose tacrolimus and myfortic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
July 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years   (Adult)
Yes
Contact: Su-Kil Park, MD.PhD 82-31-219-4467 forsake326@gmail.com
Contact: Jung-Pyo Lee, MD 82-31-219-4467 kjwa1@medimail.co.kr
Korea, Republic of
 
NCT01159080
CERL080AKR07T, CERL080AKR07T
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
January 2015

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