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

NCT01159080 | Completed Phase 4

• 1 other identifier: CERL080AKR07T
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.estimated GFR (MDRD equation) 12 months after randomization
2. 2.estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)

Conditions

Kidney Transplantation

Keywords

immunosuppression control in kidney transplantation

Outcome Measures

Primary Outcomes (1)

• estimated GFR (MDRD equation)12 months after randomization

  12 months after randomization

Secondary Outcomes (6)

• Urine protein excretion

  12 months after randomization

• graft survival

  12 month after randomization

• follow-up loss

  From randomization to 12 months after randomization

• Allograft biopsy

  From randomization to 12 months after randomization

• Treated or biopsy proven acute rejection

  From randomization to 12 months after randomization

Study Arms (2)

routine dose tacrolimus and less myfortic

ACTIVE COMPARATOR

Drug: routine dose tacrolimus and less myfortic

reduced dose tacrolimus and conventional myfortic

EXPERIMENTAL

Drug: reduced dose tacrolimus and conventional myfortic

Interventions

routine dose tacrolimus and less myfortic DRUG

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

routine dose tacrolimus and less myfortic

reduced dose tacrolimus and conventional myfortic DRUG

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

reduced dose tacrolimus and conventional myfortic

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study.
• Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months
• Patients with serum creatinine (sCr) level ≤ 2.0 mg/dL and variation of sCr \< 30% for recent 3 months
• Patients with urine proteinuria/creatinine ratio (PCR) ≤ 1 g/g, or 24 hour urine protein ≤ 1g/day for recent 3 months
• Patients who provided informed consent.

You may not qualify if:

• Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation
• Patients whose graft from non-heart beating cadaveric donor
• graft from HLA-identical living related donor
• ABO blood group incompatible donor or HLA desensitized recipients
• Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients
• Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome
• Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy)
• Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus
• 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)
• Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer
• Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months
• Patients who taken medicine from other trial within 30 days.

Sponsors & Collaborators

• Asan Medical Center: lead
• Seoul National University Hospital: collaborator
• Samsung Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Asan Medical Center, 138-736, South Korea

Location

Related Publications (1)

• Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, Kim YH, Kim JK, Oh CK, Park SK. Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study. Ann Transplant. 2018 Jun 12;23:401-411. doi: 10.12659/AOT.909036.

  PMID: 29891834 DERIVED

Study Officials

• Su-Kil Park, MD,PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of medicine, ASAN Medical CENTER

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 9, 2010
• Study Start: April 1, 2010
• Primary Completion: October 30, 2016
• Study Completion: November 30, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

KR (1)