NCT05753488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

February 21, 2023

Last Update Submit

March 1, 2023

Conditions

Renal Transplant Failure and RejectionInflammation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

ınflammation

Diagnostic Test: graft function

non inflammation

Diagnostic Test: graft function

Interventions

graft functionDIAGNOSTIC_TEST

renal transplantation

non inflammationınflammation

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients underwent renal transplantation

You may qualify if:

  • patients underwent renal transplantation

You may not qualify if:

  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rejection, PsychologyInflammation

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 3, 2023

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

TU(1)