Acute Kidney InjuryNCT05077007
Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
A study testing Percutaneous nephrolithotomy and Extracorporeal Shock Wave Lithotripsy in people with Acute Kidney Injury and Renal Calculi, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Renal Calculi, Percutaneous Nephrolithotomy
- What is being tested?
- Percutaneous nephrolithotomy and Extracorporeal Shock Wave Lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm
- Radiopaque stone
- Able and willing to give informed consent
- No history of kidney or stone disease
- Asymptomatic
- No indwelling ureteral stent
- Willing to provide medical history information
- Able and willing to give informed consent
Who cannot join
- Active urinary tract infection
- Bleeding disorder
- Chronic renal failure (eGFR<30)
- Ureteral stone
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology Department, Faculty of Medicine, Ain Shams University
Cairo, 11884
waleed Mousa, MD, 01067628771, waleedmousa2@yahoo.com
About this study
The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures
Read the detailed description
The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.
- Conditions
- Acute Kidney Injury, Renal Calculi, Percutaneous Nephrolithotomy, Extracorporeal Shockwave Lithotripsy
- Being tested
- Percutaneous nephrolithotomy, Extracorporeal Shock Wave Lithotripsy
- Keywords
- lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.
- Medical subject headings
- Acute Kidney Injury, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomyProcedure or surgery
Also called PCNL
Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
Extracorporeal Shock Wave LithotripsyProcedure or surgery
Also called ESWL
Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous nephrolithotomy | Active comparator | patients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy Receives: Procedure: Percutaneous nephrolithotomy |
| Extracorporeal Shock Wave Lithotripsy | Active comparator | patients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy Receives: Procedure: Extracorporeal Shock Wave Lithotripsy |
| control group | No intervention | Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers
Evaluation of kidney injury after procedures PCNL and ESWL by measuring the change of the level of novel non-coding lnc-RNA profile in urine
Measured: Before the procedure by 2hours and after the procedure by 2 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Jan 2021
- Primary completion22 Aug 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Responsible party
- Sponsor
- Investigators
- waleed Mousa, Principal investigator, Urology Department, Ain Shams University, Abassia, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077007
- Sponsor's protocol ID
- FMASU R 77/ 2021
- Status last verified
- Apr 2021
- First submitted
- 31 Aug 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
- ClinicalTrials.gov ID
- NCT05077007
- Acronym / sponsor ID
- FMASU R 77/ 2021
- Conditions
- Acute Kidney Injury, Renal Calculi, Percutaneous Nephrolithotomy, Extracorporeal Shockwave Lithotripsy
- Keywords
- lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 22 Aug 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures
Detailed description
The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Percutaneous nephrolithotomy | Active comparator | Procedure: Percutaneous nephrolithotomypatients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy |
| Extracorporeal Shock Wave Lithotripsy | Active comparator | Procedure: Extracorporeal Shock Wave Lithotripsypatients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy |
| control group | No intervention | –Healthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- No history of kidney or stone disease
- Asymptomatic
- No indwelling ureteral stent
- Willing to provide medical history information
- Able and willing to give informed consent
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous nephrolithotomyAlso: PCNLEndoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma | Procedure or surgery | Percutaneous nephrolithotomy |
| Extracorporeal Shock Wave LithotripsyAlso: ESWLUsing Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces. | Procedure or surgery | Extracorporeal Shock Wave Lithotripsy |
Primary outcome
Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers
Time frame: Before the procedure by 2hours and after the procedure by 2 and 24 hours
Evaluation of kidney injury after procedures PCNL and ESWL by measuring the change of the level of novel non-coding lnc-RNA profile in urine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
waleed Mousa principal investigator
Urology Department, Ain Shams University, Abassia, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrolithotomy and Extracorporeal Shock Wave Lithotripsy in people with Acute Kidney Injury and Renal Calculi, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact waleed Mousa, MD (+201067628771, waleedmousa2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers (time frame: Before the procedure by 2hours and after the procedure by 2 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.