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

NCT ID: NCT01159080

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-01
• Study Completion Date: 2016-11-30

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. 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)

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

routine dose tacrolimus and less myfortic

Group Type: ACTIVE_COMPARATOR

routine dose tacrolimus and less myfortic

Intervention Type: 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

reduced dose tacrolimus and conventional myfortic

Group Type: EXPERIMENTAL

reduced dose tacrolimus and conventional myfortic

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Su-Kil Park

Professor, Department of medicine, ASAN Medical CENTER

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Su-Kil Park, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Asan Medical Center, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29891834 (View on PubMed)

Other Identifiers

CERL080AKR07T

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CERL080AKR07T

Identifier Type: -

Identifier Source: org_study_id