MedTrace Logo

Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.

NCT04700709 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2021-01-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Sirolimus Tab.

Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/ml.

DRUG

Mycophenolate Mofetil Cap./Tab.

Up to 1g BID(total 2g daily), PO

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Kyu Ha Huh, M.D, Ph.D · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2024-12-31
Completion
2025-01-31

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 NCT04700709 on ClinicalTrials.gov