Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome

August 1, 2017 updated by: RAMahmoud, Assiut University
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.

Study Overview

Status

Status

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

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.

Detailed Description

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.The syndrome is characterized by the tetrad of nephrotic range proteinuria (>40 mg/m2/hour), hypoalbuminemia (<2.5 g/dl), generalized edema, and hyperlipidemia. It can be congenital or acquired.Currently,serum albumin, lipids, and proteinuria are the common diagnostic markers of childhood NS, but these markers may not accurately predict the outcome of individual patients because of the heterogeneity of the disease. Renal biopsy is more precise for establishing prognosis of renal outcome, but it has potential complications. Repeated monitoring is technically difficult, particularly for children. Therefore, there is still an urgent need to identify new non invasive diagnostic and prognostic biomarkers and new therapeutic targets for this disease.miRNA-30a expression in the serum of patients with nephrotic syndrome and analyzed the correlation between miRNA with largest over expression level and clinical features compared with healthy subjects.miRNA-30a expression level in drug resistant nephrotic syndrome patients was obviously higher than the drug sensitive patients and up-regulated most significantly in mesangial proliferative glomerulonephritis among different pathological types, while it decreased most obviously in glomerular lesions. miRNA-30a could be treated as the molecular marker in predict drug resistance, pathological type of nephrotic syndrome and follow up of resistant cases.

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 (Anticipated)

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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 ).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

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
Percentage of patients with highly expressed serum miRNA30-a in resistant cases of childhood nephrotic syndrome.
Time Frame: 3 days
Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.
3 days

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.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

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.
October 1, 2017

Primary Completion (Anticipated)

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.
June 1, 2019

Study Completion (Anticipated)

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.
October 1, 2019

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).
July 28, 2017

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.
July 28, 2017

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.
August 1, 2017

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.
August 2, 2017

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.
August 1, 2017

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.
August 1, 2017

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.
  • CSOAOSM

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.

Clinical Trials on Nephrotic Syndrome Steroid-Resistant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings