Protocol summary
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Study aim
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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.
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Design
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participants are assigned to two intervention and control groups using a four-way block randomization method stratified by donor type and immunological risk.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20260104068546N1
Registration date:
2026-02-18, 1404/11/29
Registration timing:
registered_while_recruiting
Last update:
2026-08-08, 1405/05/17
Update count:
1
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Registration date
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2026-02-18, 1404/11/29
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-01-21, 1404/11/01
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Expected recruitment end date
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2027-01-21, 1405/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of calcitriol on the incidence of acute rejection among kidney transplant recipients, A pilot, double-blind, randomized placebo-controlled clinical trial
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Public title
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Calcitriol in acute kidney transplant rejection
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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block
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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participants, principle investigator particularly in investigator initiated trials, healthcare providers, data collectors are blind in this study.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-01-07, 1404/10/17
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1404.142
Health conditions studied
1
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Description of health condition studied
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kidney transplantation, acute rejection atfer kidney transplantation
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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incidence of acute rejection
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Timepoint
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during first 3 months post kidney transplantation
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Method of measurement
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kidney biopsy proven or clinical suspicion with clinical cure post corticostroid puls administration.
Secondary outcomes
1
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Description
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comparison of time of first acute rejection episode between two group
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Timepoint
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during first 3 months post transplant
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Method of measurement
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biopsy proven or clinically suspicion which responds to corticostroid puls.
2
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Description
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comparison of allograft function based on eGFR between two groups
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Timepoint
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3 months post transplantation
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Method of measurement
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measurement of eGFR based on MDRD formula
3
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Description
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comparison of incidence and kind of infection episodes between two groups
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Timepoint
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during 3 months post kidney transplantation
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Method of measurement
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clinical observation and laboratory findings
4
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Description
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comparison of hospital stay during first hospitalisation post transplantation
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Timepoint
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during 3 months post kidney transplantation
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Method of measurement
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hospital documentation
5
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Description
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comparison of patient survival and graft survival
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Timepoint
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during 3 months post kidney transplantation
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Method of measurement
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observation
Intervention groups
1
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Description
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Intervention group: two pearl of calcitriol 0.25 micrograms per-oral for one month
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Category
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Prevention
2
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Description
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Control group: two pearl of placebo per-oral for one month
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available