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

Nephrotic Syndrome Steroid-Resistant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03235128
• Other study ID #: CSOAOSM
• Status: Not yet recruiting
• Phase: N/A
• First received: July 28, 2017
• Last updated: August 1, 2017
• Start date: October 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Hanan Omar Mohamed, Professor Doctor
• Phone: 01223971654
• Email: hannahomer[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Nephrotic Syndrome Steroid-Resistant
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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