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

Kidney Transplantation Clinical Trial

Official title:

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]

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04700709
• Other study ID #: B110_01KT2002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2021
• Est. completion date: January 2025

Study information

• Verified date: January 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Kyu Ha Huh, M.D, Ph.D
• Phone: +82-2-2228-2138
• Email: KHHUH[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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.
• Mycophenolate Mofetil Cap./Tab.
Up to 1g BID(total 2g daily), PO

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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