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

• Sponsor: Ankara City Hospital Bilkent (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05753488
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 14.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Failure and Rejection; Inflammation	Diagnostic Test: graft function

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Effect of Biomarkers of Inflammation on Graft Function
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
ınflammation	Diagnostic Test: graft function; renal transplantation
non inflammation	Diagnostic Test: graft function; renal transplantation

Outcome Measures

Primary Outcome Measures

1. RDW [baseline]

   Red Cell Distribution Width

2. PNI [baseline]

   prognostic nutrition index (PNI) calculated as 10 × serum albumin (g/dl) + 0.005 × total lymphocyte count (per mm3)

3. De Ritis [baseline]

   De Ritis described the ratio between the serum levels of aspartate transaminase (AST) and alanine transaminase (ALT)

4. graft function [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients underwent renal transplantation

Exclusion Criteria:

• patient refusal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey	06800

Sponsors and Collaborators

• Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ismail aytaç, Principal investigator, Ankara City Hospital Bilkent
• ClinicalTrials.gov Identifier: NCT05753488
• Other Study ID Numbers: E1-23-3250
• First Posted: Mar 3, 2023
• Last Update Posted: Mar 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Mar 3, 2023