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Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation

NCT03968588 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-05-30

No results posted yet for this study

Summary

A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) versus standard-dose tacrolimus with reduced-dose MMF.

Conditions

  • Disorder Related to Renal Transplantation

Interventions

DRUG

Tacrolimus(reduced), Mycophenolate mofetil(standard)

tacrolimus target trough blood level: 3\~8ng/mL MMF dose: 1.5\~2g/d

DRUG

Tacrolimus(standard), Mycophenolate mofetil(reduced)

tacrolimus target trough blood level: 5\~15ng/mL MMF dose: 0.5\~1g/d

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Chang-Kwon Oh, M.D · Department of surgery, Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-29
Primary Completion
2016-11-11
Completion
2017-06-14

Countries

  • South Korea

Study Locations

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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 NCT03968588 on ClinicalTrials.gov