MedTrace Logo

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

NCT01159080 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2017-03-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Su-Kil Park, MD,PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-01
Primary Completion
2016-10-30
Completion
2016-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159080 on ClinicalTrials.gov