Comparing de novo versus delayed tacrolimus administration on allograft function in kidney transplant recipients: a randomized, open-label, clinical trial
The purpos of the study: Comparing the effects of rapid versus delayed tacrolimus initiation on graft function during the first three months after kidney transplantation.
Study design: Randomized, open-label, phase three clinical trial
The method of study:
a-The study population:Inclusion criteria; all patients ≥ 14 years who will receive first kidney transplantation and they're immunosuppressive regimen regimen contains thymoglobulin induction along with mycophenolate, tacrolimus and prednisolone as maintenance regimen.
Exclusion criteria:Patients who have multiple organ transplantation.
Sample size: 25 patients in each group.
b-Intervention or interventions studied: one group of patients will be administered tacrolimus from a few hours before transplantation at a dose of 0.08 to 0.1 mg / kg / day in two divided doses and continue from the first day after transplantation (with the target level of 8-10 ng / ml) . The second group will start tacrolimus with the same dose from the third day after transplantation.
c-Intervention time: First three days after kidney transplantation.
d-The primary outcome or consequences studied:
-Dialy evaluation of serum creatinine and urine output and required dialysis during hospitalization.
-Comparing the incidence and duration of DGF and ATN during hospitalization
-Comparing the incidence of acute rejection within the first 3 months after transplantation
-Compare the serum creatinine concentrations at the discharge time
-Compare rates of graft survival within first 3 months after transplantation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604253043N11
Registration date:2016-05-21, 1395/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental (Tehran University of Medical Sciences)
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing de novo versus delayed tacrolimus administration on allograft function in kidney transplant recipients: a randomized, open-label, clinical trial
Public title
Comparing the starting time of tacrolimus administration in management of kidney transplant recipients
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 14 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, 16 Azar St., Enghelab St, Tehran, Iran.
City
Tehran
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.TUMS.REC.1395.2575
Health conditions studied
1
Description of health condition studied
Kidney transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
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
2
Description
Recipient's urine output
Timepoint
Before transplantation and daily during hospitalization
Method of measurement
Graduated container in ml/day
3
Description
Incidence of DGF
Timepoint
During first week after transplantation
Method of measurement
Need for dialysis
Secondary outcomes
1
Description
Graft survival
Timepoint
First three months after transplantation
Method of measurement
Number of functioning kidney
2
Description
The incidence of acute rejection
Timepoint
During the first three months after transplantation
Method of measurement
Based on function of transplanted kidney
Intervention groups
1
Description
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 and urine output will be assessed daily during hospitalization. Serum creatinine witll be assessed monthly after hospital discharge up to month 3 after kidney transplantatioد.
Tacrolimus whole blood concentrations will be checked twice weekly during hospitalizations and monthly thereafter up to month 3 after transplantation.
Category
Prevention
2
Description
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 creatinine and urine output will be assessed daily during hospitalization. Serum creatinine witll be assessed monthly after hospital discharge up to month 3 after kidney transplantation.
Tacrolimus whole blood concentrations will be checked twice weekly during hospitalizations and monthly thereafter up to month 3 after transplantation.