Urinary NGAL and KIM-1 After ESWL

January 5, 2026 updated by: Marmara University

Prospective Evaluation of the Effect of Different Intervals Between Extracorporeal Shock Wave Lithotripsy (ESWL) Sessions on Potential Renal Injury Using Urinary NGAL and KIM-1 Biomarkers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34854
        • Marmara University School of Medicine Urology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients undergoing extracorporeal shock wave lithotripsy (SWL)
Other: No Interventions
No study-specific intervention; patients receive standard-of-care SWL.
Other: No intervention
No study-specific intervention; patients receive standard-of-care SWL.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in urinary NGAL level
Time Frame: Within 2 weeks after completion of the third SWL session
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
Time Frame: Within 2 weeks after completion of the third SWL session
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals
Time Frame: Within 2 weeks after completion of the third SWL session
Within 2 weeks after completion of the third SWL session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAR.UAD.0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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