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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749356
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: TacroBell SR cap. Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 5, 2018
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Once-Daily Tacrolimus
One arm: TacroBell SR Cap.
 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.
Other Name: Tacrolimus SR cap.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of biopsy-confirmed acute rejection(TCMR, AMR) [ Time Frame: until 24 weeks ]
    The frequency and Incidence

  2. Pathological results of acute rejection [ Time Frame: until 24 weeks ]
    By Banff classification categories

  3. Survival rate of transplated organ [ Time Frame: at 24 weeks ]
    Kaplan-Meier

  4. Survival rate of Patients [ Time Frame: at 24 weeks ]
    Kaplan-Meier

  5. Serum-Cr, eGFR [ Time Frame: at 24 weeks ]
    eGFR using CKD-epi method

  6. Evaluate safety of TacroBell SR. cap. from number of participants with adverse events [ Time Frame: until 24 weeks ]
    safety data


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749356


Locations
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Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Yu Seun Kim, Ph.D Severance Hospital
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03749356    
Other Study ID Numbers: 211KT18008
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action