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

• Conditions: Nephrotic Syndrome Steroid-Resistant
• Interventions: 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.

• Registration Number: NCT03235128
• Lead Sponsor: Assiut University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Status Verified: 2017-08
• Study First Posted: 2017-08-01
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02
• Study Start: 2017-10-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group4	‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.	Refractory nephrotic syndrome(10 cases).
Group2	‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.	Steroid resistant nephrotic syndrome(10 cases).
Group3	‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.	immunosuppressive resistant nephrotic syndrome(10 cases).
Group1	‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.	Steroid sensitive nephrotic syndrome(10 cases).
Group5	‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.	Normal children as a healthy control group(5 cases).

Primary Outcome Measures

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