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Clinical Trials/NCT03749356
NCT03749356CompletedPhase 4

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

Chong Kun Dang Pharmaceutical1 site in 1 country141 target enrollmentStarted: September 5, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
141
Locations
1
Primary Endpoint
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Once-Daily Tacrolimus

Experimental

One arm: TacroBell SR Cap.

Intervention: TacroBell SR cap. (Drug)

Outcomes

Primary Outcomes

Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)

Time Frame: until 24 weeks

The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)

Secondary Outcomes

  • Incidence of biopsy-confirmed acute rejection(TCMR, AMR)(until 24 weeks)
  • Survival rate of transplated organ(at 24 weeks)
  • Pathological results of acute rejection(until 24 weeks)
  • Survival rate of Patients(at 24 weeks)
  • Serum-Cr, eGFR(at 24 weeks)
  • Evaluate safety of TacroBell SR. cap. from number of participants with adverse events(until 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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