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

NCT03749356 | Completed Phase 4

• 1 other identifier: 211KT18008
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of biopsy-confirmed acute rejection(TCMR, AMR)

  until 24 weeks

• Pathological results of acute rejection

  until 24 weeks

• Survival rate of transplated organ

  at 24 weeks

• Survival rate of Patients

  at 24 weeks

• Serum-Cr, eGFR

  at 24 weeks

Study Arms (1)

Once-Daily Tacrolimus

EXPERIMENTAL

One arm: TacroBell SR Cap.

Drug: TacroBell SR cap.

Interventions

TacroBell SR cap. DRUG

* 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.

Also known as: Tacrolimus SR cap.

Once-Daily Tacrolimus

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Study Officials

• Yu Seun Kim, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 21, 2018
• Study Start: September 5, 2018
• Primary Completion: July 30, 2020
• Study Completion: December 4, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

KR (1)