Circulating Factors in Nephrotic Syndrome

Not yet recruiting

• Conditions: Minimal Change Disease; Primary Focal Segmental Glomerulosclerosis; Membranous Nephropathy; Nephrotic Syndrome
• Interventions: Other: Observation

• Registration Number: NCT06315504
• Lead Sponsor: Iain Bressendorff

Brief Summary

A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-16
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-19
• Study Start: 2024-04-01
• Primary Completion: 2034-04-01
• Study Completion: 2034-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Age ≥ 18 years
• Plasma albumin < 36 g/L
• Urine protein >3.5 g/day or urine protein/creatinine-ratio (UPCR) > 3.5 or urine albumin/creatinine-ratio (UACR) >2200 mg/g
• Planned kidney biopsy
• Able to give written informed consent

Exclusion Criteria

• Kidney transplant recipient
• Previously undergone a kidney biopsy
• Unable to understand written information in Danish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with de novo nephrotic syndrome	Observation	-

Primary Outcome Measures

Name	Time	Method
levels of anti-nephrin in blood by ELISA	up to 12 months	temporal association of anti-nephrin with clinical remission of nephrotic syndrome

Secondary Outcome Measures

Name	Time	Method
changes in auto-antibodies in blood associated with membranous nephropathy	up to 24 months	temporal association of auto-antibodies with clinical remission of nephrotic syndrome