The Effect of Biomarkers of Inflammation on Graft Function in Kidney Transplantation

The Effect of Biomarkers of Inflammation on Graft Function

The aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Renal Transplant Failure and Rejection
• Intervention / Treatment: Diagnostic test: graft function

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients underwent renal transplantation

Description

Inclusion Criteria:

• patients underwent renal transplantation

Exclusion Criteria:

• patient refusal

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ınflammation	Diagnostic test: graft function; renal transplantation
non inflammation	Diagnostic test: graft function; renal transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RDW	Red Cell Distribution Width	baseline
PNI	prognostic nutrition index (PNI) calculated as 10 × serum albumin (g/dl) + 0.005 × total lymphocyte count (per mm3)	baseline
De Ritis	De Ritis described the ratio between the serum levels of aspartate transaminase (AST) and alanine transaminase (ALT)	baseline
graft function		through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Estimate): March 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: E1-23-3250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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