kidney transplantation, acute rejection atfer kidney transplantation.
Conditions
Interventions
Intervention 1: Intervention group: two pearl of calcitriol 0.25 micrograms per-oral for one month. Intervention 2: Control group: two pearl of placebo per-oral for one month.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: living/deceased donor kidney transplant patients in imam khomeini hospital aged over 18 years old serum calcium less than 10.5 mg/dL serum phosphorus less than 6 mg/dL
Exclusion criteria
Exclusion criteria: Participate in other interventional clinical studies at the same time retransplantation pregnancy or lactation Simultaneous transplantation of multiple organs Previous intolerance/allergy to vitamin D supplements or calcitriol History of desensitization for transplantation Blood iPTH level less than 50 pg/dL Blood 25 OH-vitamin D3 level over 100 ng/mL Cold ischemia duration more than 4 hours Patient's lack of consent to the study Not receiving defined immunosuppression regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute rejection. Timepoint: during first 3 months post kidney transplantation. Method of measurement: kidney biopsy proven or clinical suspicion with clinical cure post corticostroid puls administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of time of first acute rejection episode between two group. Timepoint: during first 3 months post transplant. Method of measurement: biopsy proven or clinically suspicion which responds to corticostroid puls.;Comparison of allograft function based on eGFR between two groups. Timepoint: 3 months post transplantation. Method of measurement: measurement of eGFR based on MDRD formula.;Comparison of incidence and kind of infection episodes between two groups. Timepoint: during 3 months post kidney transplantation. Method of measurement: clinical observation and laboratory findings.;Comparison of hospital stay during first hospitalisation post transplantation. Timepoint: during 3 months post kidney transplantation. Method of measurement: hospital documentation.;Comparison of patient survival and graft survival. Timepoint: during 3 months post kidney transplantation. Method of measurement: observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactOfogh Bigdeli
Tehran University of Medical Sciences
Outcome results
None listed