Disorder Related to Renal Transplantation Clinical Trial
Official title:
Comparative Clinical Study of Reduced Dose of Tacrolimus and Standard Dose of Mycophenolate Mofetil vs. Conventional Dose of Tacrolimus and Reduced Dose of Mycophenolate Mofetil in De Novo Renal Transplant Recipients
Verified date | May 2019 |
Source | Ajou University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | June 14, 2017 |
Est. primary completion date | November 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Recipients (aged 20-65) of a single (first or second) renal allograft from living or deceased donor. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonbuk National University Hospital | Jeonju | |
Korea, Republic of | Gangnam Severance Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon |
Lead Sponsor | Collaborator |
---|---|
Ajou University School of Medicine |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | renal graft function | assessed with eGFR by MDRD formula | 6 months post-transplant | |
Secondary | incidence of treatment failure | biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss | 6 months post-transplant | |
Secondary | recipients and grafts' survival rates | recipients and grafts' survival rates | 6 months post-transplant | |
Secondary | 24-hour urine proteinuria and creatinine clearance | 24-hour urine proteinuria and creatinine clearance | 6 months post-transplant |
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