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

• Status: Completed
• Trial end date: 2017-06-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Treatments: Mycophenolic Acid; Tacrolimus

Criteria

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