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

Phase 4

Not yet recruiting

• Conditions: Kidney Transplantation
• Interventions: Drug: Mycophenolate Mofetil Cap./Tab.; Drug: Sirolimus Tab.

• Registration Number: NCT04700709
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 158

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolate Mofetil Tablet/Capsule	Mycophenolate Mofetil Cap./Tab.	ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.
RaparoBell® Tablet	Sirolimus Tab.	ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.

Primary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	Until 48 weeks after taking medicine	Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure

Secondary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	Until 24 weeks after taking medicine	Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure
The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy	Until 24weeks and 48weeks after taking medicine	Banff Criteria
Incidence of CMV, BKV infection	Until 24weeks and 48weeks after taking medicine	Incidence of CMV, BKV infection
Incidence of biopsy-confirmed acute rejection	Until 24weeks and 48weeks after taking medicine	Banff Criteria
Survival rate	Until 24weeks and 48weeks after taking medicine	transplanted organ and patients
Function of Kidney	Until 24weeks and 48weeks after taking medicine	eGFR using MDRD(Modification of Diet in Renal Disease) method

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of