The effect of calcitriol on the incidence of acute rejection among kidney transplant recipients, A pilot, double-blind, randomized placebo-controlled clinical trial
Comparison of the incidence of acute rejection; kidney function based on eGFR; patient survival and allograft survival during during the first three months after kidney transplantation between the two groups.
Design
participants are assigned to two intervention and control groups using a four-way block randomization method stratified by donor type and immunological risk.
Settings and conduct
The study is conducted in the kidney transplant department of Imam Khomeini Hospital in Tehran. The drug group receives two 0.25 mcg pearl of Calcitriol daily and the control group received two placebo pearl daily. Participants, health care personnel, data collectors and those who evaluate the outcomes are kept blind to the allocation of study groups. Patients who are vitamin D3 deficient will be treated with vitamin D3 pearl in addition to receiving calcitriol or placebo.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age who are not pregnant or lactating, have a serum calcium level of less than 6 mg/dL and a serum phosphorus level of less than 10.5 mg/dL, are undergoing their first transplant, have no history of desensitization and are not receiving another organ transplant at the same time enter this study. Patients with iPTH less than 50 pg/ml or D3 levels over 100 ng/ml or those not using immunosuppressive regimen are excluded from the study.
Intervention groups
The intervention group will receive calcitriol pearl at a dose of 0.5 micrograms daily and the control group will receive placebo pearl immediately after transplantation along with an impressiveness regimen for one month.
Main outcome variables
Investigation of the effectiveness of calcitriol immediately after transplantation on the incidence of acute rejection cases; allograft function and graft survival in the first trimester after kidney transplantation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260104068546N1
Registration date:2026-02-18, 1404/11/29
Registration timing:registered_while_recruiting
Last update:2026-02-18, 1404/11/29
Update count:0
Registration date
2026-02-18, 1404/11/29
Registrant information
Name
ofogh bigdeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 8709
Email address
ofogh.bigdeli@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of calcitriol on the incidence of acute rejection among kidney transplant recipients, A pilot, double-blind, randomized placebo-controlled clinical trial
Public title
Calcitriol in acute kidney transplant rejection
Purpose
Prevention
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
block
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigator particularly in investigator initiated trials, healthcare providers, data collectors are blind in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina st, 16Azar st, Keshavarz Blvd,Tehran