Kidney transplantation in adult recipients receiving tacrolimus based immunosuppressive therapy during the early post transplantation period.. Kidney transplant status
Conditions
Interventions
Intervention 1: Intervention group: Participants receive once daily extended release tacrolimus (Advagraf®, Astellas) at a starting dose of 5 milligrams per day as part of a standardized immunosuppres
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All patients at this center have received a kidney transplant from a deceased and brain-dead donor Adult recipients (age = 18 years) undergoing their first kidney transplant. Willingness and ability to provide written informed consent as they are to receive a tacrolimus-based immunosuppressive regimen.
Exclusion criteria
Exclusion criteria: Recipients of multiple organ transplants Patients undergoing retransplantation Known sensitivity to tacrolimus or its excipients ABO blood group incompatible transplant Pregnant or lactating women Desire to use a specific dosage form of Tacrolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy proven acute rejection within the first month after kidney transplantation. Timepoint: During the first four weeks after kidney transplantation. Method of measurement: For cause kidney biopsy performed in cases of suspected acute rejection or unexplained increase in serum creatinine, with histopathological confirmation by a transplant pathologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal graft function assessed by serum creatinine level. Timepoint: Day 1, Day 2, Week 1, Week 2, Week 3, and Week 4 after kidney transplantation. Method of measurement: Serum creatinine measured using standard laboratory methods. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNakisa Rasaei
Shiraz University of Medical Sciences
Outcome results
None listed