The Frequency and Risk Factors of Delayed Graft Function

The Frequency and Risk Factors of Delayed Graft Function in Living Donor Kidney Transplantation and Its Clinical Impact in Part of Middle East

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant; Complications; Delayed Graft Function
• Intervention / Treatment: Procedure: living kidney transplantation

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.

• Study Type: Observational
• Enrollment (Actual): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
living kidney transplanted patients; Any patients over 18 who received kidney transplantation from living donor	Procedure: living kidney transplantation; receiving kidney transplantation from living donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of delayed graft function	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
risk factors of DGF	three years

Collaborators and Investigators

• Sponsor: nooshin dalili
• Investigators: Principal Investigator: Shahid Beheshti University of Medical Sciences, Medical, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function
• Other Study ID Numbers: SB24576H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No