Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

Kidney Transplantation Clinical Trial

Official title:

Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193565
• Other study ID #: B110_02KT2103
• Status: Recruiting
• Phase: Phase 4
• Start date: November 19, 2021
• Est. completion date: June 2024

Study information

• Verified date: December 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Chul Woo Yang, Ph.D
• Phone: 82-2-2258-6037
• Email: yangch[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Description:

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients who at least 1 year and less than 10 years after kidney transplantation

2. Over 20 years old

3. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

Exclusion Criteria:

1. Patients who have transplanted organs other than kidney

2. At the time of Screening

• 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

• Protein/Creatinine ratio=1.0(mg/mg)

3. Patents who had a record of taking mTOR inhibitor before 3 months

4. In investigator's judgement

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Sirolimus
Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8ng/mL
• Mycophenolate mofetil
Up to 1g BID(total 2g daily), PO

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul, St.Mary's 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-confirmed acute rejection, graft loss, death, or follow-up failure	Until 24 weeks
Secondary	Incidence of biopsy-confirmed acute rejection(TCMR, AMR)	The frequency and Incidence	Until 24 weeks
Secondary	Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy	By Banff classification categories	Until 24 weeks
Secondary	Survival rate of transplanted organ	Kaplan-Meier	Until 24 weeks
Secondary	Survival rate of Patients	Kaplan-Meier	Until 24 weeks
Secondary	Serum-Cr, eGFR	eGFR using MDRD	Until 24 weeks
Secondary	Incidence of BKV, CMV infection	The frequency and Incidence	Until 24 weeks