The Effect of Biomarkers of Inflammation on Graft Functio... | NCT05753488

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

NCT05753488

Sponsor

Ankara City Hospital Bilkent

Status

Unknown status

Last Update Posted

Mar 3, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Renal Transplant Failure and Rejection
Inflammation

Interventions

graft function

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Aug 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Mar 1, 2023

First Posted Date

Mar 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2023

Last Update Posted Date

Mar 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ismail aytaç, Principal investigator, Ankara City Hospital BilkentPrincipal Investigator

Lead Sponsor

Ankara City Hospital BilkentOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ınflammation			Diagnostic Test: graft function
non inflammation			Diagnostic Test: graft function

Interventions

Name	Type	Description	Arm Group Labels	Other Names
graft function	Diagnostic Test	renal transplantation	non inflammation ınflammation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients underwent renal transplantation

Exclusion Criteria:

patient refusal

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients underwent renal transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara City Hospital		Ankara		06800	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012059	Rejection, Psychology
D007249	Inflammation

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided