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

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Sirolimus Tab.; Drug: Mycophenolate Mofetil Cap./Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04700709

B110_01KT2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

[Time of Screening]

1. Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
2. More than the age of 19 years old
3. Agreement with written informed consent

[Time of Randomization]

1. Patients who have transplanted Kidney within 4 weeks(25 days to 35 days)
2. Patients who take CNI plus MMF after kidney transplantation

Exclusion criteria

[Time of Screening]

1. Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
2. PRA > 50% before desenitization or positive results of DSA
3. Receive a kidney from a related donor who showed HLA identical
4. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
5. Allergic/hypersensitivity reaction in the history of Investigational drugs or additives
6. Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
7. Patient has conversation impairment because of mental illness within 6months
8. Participated in other trial within 4 weeks
9. In investigator's judgement

[Time of Randomization]

1. Patients with acute rejection who have been clinically treated after kidney transplantation

2. At the time of Randomization

   • Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
   • WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/mm^3

3. Patients who had plasmapheresis within 1 week

4. Patents who had a record of taking mTOR inhibitor before

5. In investigator's judgement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

RaparoBell® Tablet

Experimental group

Description:

ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.

Treatment:

Drug: Sirolimus Tab.

Mycophenolate Mofetil Tablet/Capsule

Active Comparator group

Description:

ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.

Treatment:

Drug: Mycophenolate Mofetil Cap./Tab.