Biomarkers NGAL, IL 18 as Predictors of Acute Kidney Inju... | NCT03605264

Studies
Biomarkers NGAL, IL 18 as Predictors of Acute Kidney Injury in Renal Transplant Recipients

NCT03605264

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Completed

Last Update Posted

Oct 25, 2021Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Kidney Transplant; Complications
Acute Kidney Injury

Interventions

Not provided

Countries

Not provided

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Jan 15, 2017Actual

Completion Date

Feb 15, 2017Actual

First Submitted Date

Jul 20, 2018

First Submission Date that Met QC Criteria

Jul 20, 2018

First Posted Date

Jul 30, 2018Actual

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

Oct 18, 2021

Last Update Posted Date

Oct 25, 2021Actual

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

New markers of AKI including plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) and Interleukin 18(IL-18) may form a biomarker panel that may help predict AKI earlier in the course of disease than creatinine.

Biomarkers for renal injury decreases following successful Renal transplantation. The level of decrease in biomarkers, correlates with the renal graft function, and this fall occurs earlier than the fall in creatinine and/or increase in the Urine output. Should graft dysfunction occurs, investigating the fall in biomarkers could provide a window of opportunity for therapeutic interventions and also guide in evaluating the effectiveness of such interventions. NGAL is a 25 kilo Dalton(kDa) ligand-binding protein of the lipocalin family, present in human tissues including kidney. NGAL is induced early in ischemic or nephrotoxic injury to the kidney. It has also been evaluated as a biomarker of acute injury in kidney transplantation. Interleukin (IL)-18 is synthesized as an inactive 23 kDa precursor by several tissues including monocytes, macrophages, and proximal tubular epithelial cells. Urine IL-18 is elevated in patients with acute tubular necrosis and in urinary tract infection, chronic renal insufficiency, and prerenal azotemia.

Delayed graft function and slow graft function are associated with poor graft survival at one year. Early prediction of graft dysfunction could help prognosticate and initiate renoprotective measures. Urine biomarkers including NGAL and IL 18 have shown promise in this regard, but it may be fraught with risk of biomarker dilution, an effect of urinary flow rate on biomarker levels. The investigators hypothesized that plasma NGAL and plasma IL-18 can detect reduced renal graft function in renal transplant recipients within the first 2 postoperative days.

Detailed Description

Creatinine is widely used as a marker of kidney function. The use of Creatinine has many confounding factors, and it rises only after loss of 50% of renal function. This time lost in rise of serum creatinine gives rise to the risk of missing time window that may be used to prevent progress of Acute Kidney Injury (AKI).

NGAL and IL 18 are a panel of new biomarkers associated with acute kidney injury, and their levels correlate with an improvement of graft function in renal transplant recipients. Precise and early detection of a failing graft can prompt multiple investigations and interventions which may ultimately aid in maintaining the graft.

The serum levels were measured to avoid the dilution effect and output variability of urine samples.

The investigators measure the serum NGAL and IL-18 for the first 2 post-operative days after renal transplantation, and check if the trends correlate with long term graft survival and function.

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

Retention

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Slow Graft Function		Slow Graft function(SGF) is defined as a failure of serum creatinine to fall by 70% at postoperative day 7 after renal transplantation.
Immediate Graft Function		Immediate graft function(IGF) is defined as a fall of serum creatinine of 70% at postoperative day 7 after renal transplantation.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Slow Graft Function	failure of serum creatinine to fall by 70% at postoperative day 7 after renal transplantation.	7 days
Early Graft Loss(EGL)	Early Graft Loss was defined as graft nephrectomy or loss of kidney transplant function resulting in the recipient becoming dialysis dependent within 30 days of kidney transplantation (and never achieving graft function thereafter) or death with a non-functioning graft within 30 days	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing renal transplant surgery

Exclusion Criteria:

Patients with sepsis
Patients diagnosed with malignancy
Patients on immunosuppressants for other indications
Denial to participation
Patients undergoing re-transplantation
Pregnant Women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

The study population is patients undergoing renal transplantation

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided