An observational study in Delayed Graft Function and Kidney Transplant; Complications, sponsored by nooshin dalili. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-13.
Sponsored by nooshin dalili · Observational
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.
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.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 500 is above the median of 125 across 16 observational studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →nooshin dalili is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
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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
Any patients over 18 who received kidney transplantation from living donor
Procedure: living kidney transplantation
receiving kidney transplantation from living donor
incidence of delayed graft function
Time frame: 3 years
risk factors of DGF
Time frame: three years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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