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

Phase 4

Completed

• Conditions: Kidney Transplant
• Interventions: Drug: TacroBell SR cap.

• Registration Number: NCT03749356
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-05
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Primary Completion: 2020-07-30
• Study Completion: 2020-12-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Once-Daily Tacrolimus	TacroBell SR cap.	One arm: TacroBell SR Cap.

Primary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)	until 24 weeks	The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)

Secondary Outcome Measures

Name	Time	Method
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)	until 24 weeks	The frequency and Incidence
Survival rate of transplated organ	at 24 weeks	Kaplan-Meier
Pathological results of acute rejection	until 24 weeks	By Banff classification categories
Survival rate of Patients	at 24 weeks	Kaplan-Meier
Serum-Cr, eGFR	at 24 weeks	eGFR using CKD-epi method
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events	until 24 weeks	safety data

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of