Comparing the starting time of tacrolimus administration in management of kidney transplant recipients

Comparing de novo versus delayed tacrolimus administration on allograft function in kidney transplant recipients: a randomized, open-label, clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201604253043N11

Enrollment

Registered

2016-05-21

Start date

2016-05-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant. Kidney transplant status

Interventions

Intervention 1: Intervention 1: Tacrolimus will be started from a few hours before transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses ( The target level of 8-10 ng / ml). Ser

Prevention

Intervention 1: Tacrolimus will be started from a few hours before transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses ( The target level of 8-10 ng / ml). Serum creatinine a

Intervention 2:Tacrolimus will be started from the third day after kidney transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses (The target level of 8-10 ng / ml). Serum cre

Eligibility

Sex/Gender

All

Age

14 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients who underwent the first of Deceased donor or Living donor kidney transplantation in Imam Khomeini Hospital Complex, Tehran, Iran ; Age is = 14 y ; Patients who receive thymoglobulin induction ; Patients who receive Mycophenolate and Prednisone plus Tacrolimus as immunosuppressive regimen. Exclusion criteria: Patients with unstable cardiac, hepatic, pulmonary functions after kidney transplantation ; Patients who have multiple organ transplantation ; Patients with known malignancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Recipient's serum creatinine. Timepoint: Before the transplantation, every 6 hours on the first day of transplant, then daily during hospitalization, then weekly until the end of the first month after transplant, then monthly until the end of the third month after transplat. Method of measurement: Blood samples in laboratories in milligrams / deciliter.;Recipient's urine output. Timepoint: Before transplantation and daily during hospitalization. Method of measurement: Graduated container in ml/day.;Incidence of DGF. Timepoint: During first week after transplantation. Method of measurement: Need for dialysis.	—

Measure

Time frame

Recipient's serum creatinine. Timepoint: Before the transplantation, every 6 hours on the first day of transplant, then daily during hospitalization, then weekly until the end of the first month after transplant, then monthly until the end of the third month after transplat. Method of measurement: Blood samples in laboratories in milligrams / deciliter.;Recipient's urine output. Timepoint: Before transplantation and daily during hospitalization. Method of measurement: Graduated container in ml/day.;Incidence of DGF. Timepoint: During first week after transplantation. Method of measurement: Need for dialysis.

—

Secondary

Measure	Time frame
Graft survival. Timepoint: First three months after transplantation. Method of measurement: Number of functioning kidney.;The incidence of acute rejection. Timepoint: During the first three months after transplantation. Method of measurement: Based on function of transplanted kidney.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Maryam Ghadimi

Department of Clinical Pharmacy, Tehran University of Medical Sciences

ghadimimaryam4449@yahoo.com+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026