Nephrotic SyndromeNCT05912673
Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome
An observational study of Nephrotic Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
The use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome to detect steroid resistance and to use it as a prognostic instrument of the progression of the disease. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- renal doppler
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2023to 30 Aug 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 60 children and adolescents with nephrotic syndrome who will be diagnosed and followed at our nephrology Unit and Clinic at TUH during the period of the study.
Who may be able to join
- Pediatric patients with primary nephrotic syndrome aged from 1 to 18 years
Who cannot join
- - Patients with congenital nephrotic syndrome.
- Patients with secondary causes of nephrotic syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome
The use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome to detect steroid resistance and to use it as a prognostic instrument of the progression of the disease.
Read the detailed description
Renal Doppler will be done for all children in supine and lateral positions using Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity) at diagnosis, after one month, 3 months and 6months, in which these values will be obtained by the ultrasound machine based on the computer algorithm. Also the kidneys will be scanned firstly for length, width, cortical thickness and echogenicity.
- Conditions
- Nephrotic Syndrome
- Being tested
- renal doppler
- Keywords
- renal doppler, nephrotic syndrome, steroid resistance
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal dopplerDevice
Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome
measurement of renal resistive index and detection of steroid sensitivity
Measured: 6 weeks
Secondary outcomes (1)
progression of nephrotic syndrome
frequent measurement of renal resistive index and using it as prognostic factor
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start28 Jan 2023
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mabrouk Elghoul, Tanta University
- Investigators
- Sara Mabrouk Mohamed Elghoul, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912673
- Sponsor's protocol ID
- 36264PR25/1/23
- Status last verified
- Jan 2024
- First submitted
- 11 Jun 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT05912673
- Acronym / sponsor ID
- 36264PR25/1/23
- Conditions
- Nephrotic Syndrome
- Keywords
- renal doppler, nephrotic syndrome, steroid resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 22 Jun 2023 (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 use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome to detect steroid resistance and to use it as a prognostic instrument of the progression of the disease.
Detailed description
Renal Doppler will be done for all children in supine and lateral positions using Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity) at diagnosis, after one month, 3 months and 6months, in which these values will be obtained by the ultrasound machine based on the computer algorithm. Also the kidneys will be scanned firstly for length, width, cortical thickness and echogenicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 60 children and adolescents with nephrotic syndrome who will be diagnosed and followed at our nephrology Unit and Clinic at TUH during the period of the study.
Key inclusion criteria (1 listed)
- Pediatric patients with primary nephrotic syndrome aged from 1 to 18 years
Key exclusion criteria (2 listed)
- - Patients with congenital nephrotic syndrome.
- Patients with secondary causes of nephrotic syndrome.
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 |
|---|---|---|
| renal dopplerToshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity | Device | – |
Primary outcome
detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome
Time frame: 6 weeks
measurement of renal resistive index and detection of steroid sensitivity
1 secondary outcome
progression of nephrotic syndrome
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Sara Mabrouk Mohamed Elghoul, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome, run by Tanta 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome (time frame: 6 weeks). 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 24 Jan 2024.