NCT04700709

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

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. [ART Study]

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study 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

Type	Name	Description
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

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2021-01-08
• Last updated: 2021-01-08

Locations

1 site across 1 country: South Korea