Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation

NCT03968588 | Completed Phase 4

• 1 other identifier: 062KTP14-1C
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) versus standard-dose tacrolimus with reduced-dose MMF.

Conditions

Disorder Related to Renal Transplantation

Outcome Measures

Primary Outcomes (1)

• renal graft function

  assessed with eGFR by MDRD formula

  6 months post-transplant

Secondary Outcomes (3)

• incidence of treatment failure

  6 months post-transplant

• recipients and grafts' survival rates

  6 months post-transplant

• 24-hour urine proteinuria and creatinine clearance

  6 months post-transplant

Study Arms (2)

reduced-dose tacrolimus + standard-dose MMF

EXPERIMENTAL

Tacrolimus dose was individually adjusted with a target trough blood level of between 3ng/mL and 8ng/mL throughout the study period (6 months after transplantation). MMF started within 72 hours after transplantation and the dose of MMF was 1.5\~2.0g per day.

Drug: Tacrolimus(reduced), Mycophenolate mofetil(standard)

standard-dose tacrolimus + reduced-dose MMF

ACTIVE COMPARATOR

Control group, target trough blood level was between 5ng/mL and 15ng/mL throughout the study period. MMF dose was 0.5\~1g per day and MMF started within 72 hours after transplantation.

Drug: Tacrolimus(standard), Mycophenolate mofetil(reduced)

Interventions

Tacrolimus(reduced), Mycophenolate mofetil(standard) DRUG

tacrolimus target trough blood level: 3\~8ng/mL MMF dose: 1.5\~2g/d

Also known as: TacroBell, MY-REPT

reduced-dose tacrolimus + standard-dose MMF

Tacrolimus(standard), Mycophenolate mofetil(reduced) DRUG

tacrolimus target trough blood level: 5\~15ng/mL MMF dose: 0.5\~1g/d

Also known as: TacroBell, MY-REPT

standard-dose tacrolimus + reduced-dose MMF

Eligibility Criteria

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

You may qualify if:

• Recipients (aged 20-65) of a single (first or second) renal allograft from living or deceased donor.

You may not qualify if:

• comprised of recipients with multiple organ transplants
• double kidney transplant or organs donated after cardiac death
• recipients previously organ transplanted except kidney
• ABO-incompatible transplants
• recipients with antibodies against the human leukocyte antigens of the donor organ
• history of malignancy in the previous 5 years (except successfully treated localized non-melanoma skin cancer and thyroid cancer)
• leukocyte counts of less than 2,500 per μL, or neutrophils less than 1,500 per μL, or platelets less than 50,000 per μL
• evidence of active systemic infection requiring the use of antibiotics, human immunodeficiency virus infection, or chronic active hepatitis B or C

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (4)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Study Officials

• Chang-Kwon Oh, M.D

  Department of surgery, Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chang-Kwon Oh

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: July 29, 2014
• Primary Completion: November 11, 2016
• Study Completion: June 14, 2017
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)