Circulating Factors in Nephrotic Syndrome

Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nephrotic Syndrome; Minimal Change Disease; Membranous Nephropathy; Primary Focal Segmental Glomerulosclerosis
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Estimated): 104

Contacts and Locations

• Study Contact: Name: Ditte Hansen, MD PhD; Phone Number: +4538682056; Email: ditte.hansen.04@regionh.dk
• Study Contact Backup: Name: Iain Bressendorff, MD PhD; Phone Number: +4524277139; Email: iain.oshoej.bressendorff@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

De novo nephrotic syndrome admitted to hospital for a clinically indicated kidney biopsy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with de novo nephrotic syndrome	Other: Observation; Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
levels of anti-nephrin in blood by ELISA	temporal association of anti-nephrin with clinical remission of nephrotic syndrome	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in auto-antibodies in blood associated with membranous nephropathy	temporal association of auto-antibodies with clinical remission of nephrotic syndrome	up to 24 months

Collaborators and Investigators

• Sponsor: Iain Bressendorff
• Collaborators: Ditte Hansen MD PhD; Casper Rydahl MD; Anders Nordholm MD PhD; Eva Gravesen MD PhD

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Disease; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Syndrome; Glomerulosclerosis, Focal Segmental; Nephrotic Syndrome; Nephrosis; Glomerulonephritis, Membranous; Nephrosis, Lipoid
• Other Study ID Numbers: Nephrotic Syndrome Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon reasonable request to the primary investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No