NCT05912673

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

June 11, 2023

Last Update Submit

January 22, 2024

Conditions

Nephrotic Syndrome

Keywords

renal dopplernephrotic syndromesteroid resistance

Outcome Measures

Primary Outcomes (1)

  • detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome

    measurement of renal resistive index and detection of steroid sensitivity

    6 weeks

Secondary Outcomes (1)

  • progression of nephrotic syndrome

    six months

Interventions

renal dopplerDEVICE

Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Pediatric patients with primary nephrotic syndrome aged from 1 to 18 years

You may not qualify if:

  • \- Patients with congenital nephrotic syndrome.
  • Patients with secondary causes of nephrotic syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Mabrouk Mohamed Elghoul

Tanta, Egypt

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sara Mabrouk Mohamed Elghoul, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tanta, Stadium Street

Study Record Dates

First Submitted

June 11, 2023

First Posted

June 22, 2023

Study Start

January 28, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)