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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.
Verified February 2012 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: February 20, 2012
Last verified: February 2012
History of Changes
  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: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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 350
Study Start Date: July 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159080

Contacts
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

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Asan Medical Center, Korea, Republic of, 138-736
Contact: Yun-kyoung Kim     82-31-219-4467     forsake326@ajou.ac.kr    
Contact: Jung-Pyo Lee, MD     82-31-219-4467     sporing@ajou.ac.kr    
Principal Investigator: Su-Kil Lee, MD,PhD            
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

No publications provided

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
Study First Received: July 6, 2010
Last Updated: February 20, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013