Urinary NGAL and KIM-1 After ESWL | NCT07341269

Studies
Urinary NGAL and KIM-1 After ESWL

NCT07341269

Sponsor

Marmara University

Status

Completed

Last Update Posted

Jan 14, 2026Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Urinary Stone
Renal Injury

Interventions

No Interventions
No intervention

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

Jan 2026

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

Jun 1, 2025Actual

Primary Completion Date

Aug 1, 2025Actual

Completion Date

Dec 10, 2025Actual

First Submitted Date

Dec 20, 2025

First Submission Date that Met QC Criteria

Jan 5, 2026

First Posted Date

Jan 14, 2026Actual

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

Jan 5, 2026

Last Update Posted Date

Jan 14, 2026Actual

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 goal of this prospective observational study is to evaluate the effect of different time intervals between extracorporeal shock wave lithotripsy (ESWL) sessions on renal injury using urinary biomarkers in patients with urinary system stone disease.

The main questions it aims to answer are:

Does the interval between consecutive ESWL sessions affect the degree of renal injury?

Are urinary NGAL and KIM-1 levels reliable biomarkers for detecting ESWL-related renal damage?

What is the optimal time interval between ESWL sessions to minimize renal injury?

If there is a comparison group, researchers will compare patients undergoing ESWL with different inter-session time intervals to determine whether shorter or longer intervals are associated with higher levels of renal injury biomarkers.

Participants will:

Undergo ESWL treatment for urinary system stones

Be assigned to one of two groups based on the time interval between ESWL sessions

Provide urine samples before ESWL and after three ESWL sessions

Have urinary NGAL and KIM-1 levels measured to assess renal injury

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

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing extracorporeal shock wave lithotripsy (SWL)			Other: No Interventions Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Interventions	Other	No study-specific intervention; patients receive standard-of-care SWL.	Patients undergoing extracorporeal shock wave lithotripsy (SWL)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in urinary NGAL level	Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions	Within 2 weeks after completion of the third SWL session
Change in urinary KIM-1 levels	Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions	Within 2 weeks after completion of the third SWL session

Secondary Outcomes

Measure	Description	Time Frame
Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals		Within 2 weeks after completion of the third SWL session

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 18 years and older
Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease

Exclusion Criteria:

Positive nitrite on urinalysis prior to SWL
Positive urine culture prior to SWL, defined as >10⁵ CFU/mL bacterial growth
Suspected struvite stone, based on previous or partial stone analysis
Presence of a nephrostomy tube
Presence of urinary diversion
History of bleeding disorders
Pregnancy
Use of anticoagulant therapy
History of cardiac arrhythmia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population consists of adult patients aged 18 years and older with urinary system stone disease who are undergoing extracorporeal shock wave lithotripsy (SWL) as part of routine clinical care. Participants are prospectively observed to evaluate changes in urinary NGAL and KIM-1 levels as biomarkers of renal injury associated with SWL. Patients with active urinary tract infection, suspected struvite stones, urinary diversion, nephrostomy tube, bleeding disorders, pregnancy, anticoagulant use, or cardiac arrhythmia are excluded.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University School of Medicine Urology Department		Istanbul	Istanbul	34854	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014545	Urinary Calculi

Ancestor Terms

ID	Term
D052878	Urolithiasis
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

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Browse Branches

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