Clinical trial NCT03555513: The Frequency and Risk Factors of Delayed Graft Function
Official title: The Frequency and Risk Factors of Delayed Graft Function in Living Donor Kidney Transplantation and Its Clinical Impact in Part of Middle East
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Graft Function
Kidney Transplant; Complications
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A case report data collecting form was designed for gathering the following data: the recipients and donors characteristics prior to transplantation, time on dialysis (months), first or second transplantation, panel reactive antibody (PRA) and human leukocyte antigen (HLA) mismatch, frequency of DGF, renal function, cold and warm ischemia time, immunosuppressive regimens (induction, if any used), adverse events, acute and chronic graft rejection, graft survival and patient survival at 1, 2 and 3 years follow-up.It was planned to recruit 500 patients, from 3 centers in 3 countries of Middle east. Distribution by country or region was as following :Iran (n=300), Kuwait (n=100) and KSA (n=100) subjects . As it was a retrospective disease registry with no access or possibility to recall patients, obtaining informed consent form from patients was waived up to the local regulatory processes. Approvals were obtained from each site to access patients' records and collect their data.

Brief summary: Delayed graft function (DGF) is an important phenomenon after kidney transplantation with direct and indirect implication on graft survival. Although its incidence and risk factors have been studied after cadaveric kidney transplantation cases, only few data is available regarding transplants from living donors. The present study was performed to investigate the frequency and risk factors of DGF among living-unrelated kidney transplant recipients among three transplant centers in part of Middle East.

Detailed description: In this multi-center retrospective study, data from 480 transplanted patients had been collected from existing local hospital registries in three countries (Iran, Kingdom of Saudi Arabia (KSA), and Kuwait) with 3 years post transplantation follow-up. Data for this study was collected based on routine clinical practice of medical practitioners across the participating countries. A case report data collecting form was designed for gathering the data including the recipient and donor's characteristics prior to transplantation, and after transplantation up to three years post transplantation. Using binary logistic regression analysis, the potential risk factors for occurrence of DGF in living donor transplantations were tested. Graft and patient survival at 1, 2 and 3 years depending on follow-up time was evaluated.

Eligibility criteria: Inclusion Criteria:

Living donor kidney recipients with complete prior transplantation data and 3 years post transplantation follow up, including those who died during the observation period

Exclusion Criteria:

kidney recipients younger than 18 years

Primary outcomes:
measure: incidence of delayed graft function
timeFrame: 3 years
Secondary outcomes:
measure: risk factors of DGF
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Shahid Beheshti University of Medical Sciences, Medical
role: PRINCIPAL_INVESTIGATOR
References: