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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Kidney Transplant

Treatments: Drug: TacroBell SR cap.

Study type: Interventional

Funder types: Industry

Identifiers

NCT03749356

211KT18008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Once-Daily Tacrolimus

Experimental group

Description:

One arm: TacroBell SR Cap.

Treatment:

Drug: TacroBell SR cap.