Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients

Kidney Transplant Clinical Trial

— OPIRUS  

Official title:

Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749356
• Other study ID #: 211KT18008
• Status: Completed
• Phase: Phase 4
• Start date: September 5, 2018
• Est. completion date: December 4, 2020

Study information

• Verified date: January 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.

Description:

This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 4, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Over 20 years old(male or female)

• Patients who are planning to receive a kidney from a deceased or a living non-related/related donor

• Agreement with written informed consent

Exclusion Criteria:

• Previously received organs other than kidneys or who are planed to be transplanted simultaneously

• Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient

• Receive a kidney from a related donor who showed HLA-0 mismatch (identical)

• Undergo desensitization therapy with high sensitization

• Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.]

• Patients or donors who have positive HIV test result

• Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders

• Severe systemic infection requiring treatment

• Prior to the kidney transplantation

• 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

• Pregnant women or nursing mothers

• Fertile women who not practice contraception with appropriate methods

• Participated in other trial within 4 weeks

• In investigator's judgment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• TacroBell SR cap.
Orally, once-daily in the morning After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	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 (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)	The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, 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	Pathological results of acute rejection	By Banff classification categories	until 24 weeks
Secondary	Survival rate of transplated organ	Kaplan-Meier	at 24 weeks
Secondary	Survival rate of Patients	Kaplan-Meier	at 24 weeks
Secondary	Serum-Cr, eGFR	eGFR using CKD-epi method	at 24 weeks
Secondary	Evaluate safety of TacroBell SR. cap. from number of participants with adverse events	safety data	until 24 weeks