NCT03235128

Brief Summary

Childhood nephrotic syndrome is the most frequent glomerular disease that presents during childhood,primarily owing to a disturbed immune function.This disease is characterized by alterations in selectivity at the glomerular capillary wall that lead to an inability to restrict the urinary loss of protein.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

July 28, 2017

Last Update Submit

August 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with highly expressed serum miRNA30-a in resistant cases of childhood nephrotic syndrome.

    Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

    3 days

Study Arms (5)

Group1

Steroid sensitive nephrotic syndrome(10 cases).

Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Group2

Steroid resistant nephrotic syndrome(10 cases).

Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Group3

immunosuppressive resistant nephrotic syndrome(10 cases).

Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Group4

Refractory nephrotic syndrome(10 cases).

Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Group5

Normal children as a healthy control group(5 cases).

Diagnostic Test: ‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.

Interventions

Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood

Group1Group2Group3Group4Group5

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Group1: steroid sensitive nephrotic syndrome ( 10 cases ). Group2:steroid resistant nephrotic syndrome (10 cases). Group3:immunosuppresive resistant nephrotic syndrome(10 cases). Group4:refractory nephrotic syndrome(10 cases). Group5: normal children as a healthy control group ( 5 cases ).

You may qualify if:

  • Nephrotic children aged from 2 to 18 that admitted to Pediatric Hospital.

You may not qualify if:

  • Congenital or infantile nephrotic syndrome
  • Other kidney diseases
  • Abnormal kidney function test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Teng J, Sun F, Yu PF, Li JX, Yuan D, Chang J, Lin SH. Differential microRNA expression in the serum of patients with nephrotic syndrome and clinical correlation analysis. Int J Clin Exp Pathol. 2015 Jun 1;8(6):7282-6. eCollection 2015.

    PMID: 26261628BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hanan Omar Mohamed, Professor Doctor

CONTACT

Eman Mohammed Salaheldin, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 1, 2017

Study Start

October 1, 2017

Primary Completion

June 1, 2019

Study Completion

October 1, 2019

Last Updated

August 2, 2017

Record last verified: 2017-08