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NCT06315504 Clinical Trial

Circulating Factors in Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:
Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06315504
Other study ID # Nephrotic Syndrome Cohort
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2034

Study information
Verified date March 2024
Source Herlev Hospital
Contact Iain Bressendorff, MD PhD
Phone +4524277139
Email iain.oshoej.bressendorff@regionh.dk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 104
Est. completion date April 1, 2034
Est. primary completion date April 1, 2034
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Observation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Iain Bressendorff

Outcome
Type Measure Description Time frame Safety issue
Primary levels of anti-nephrin in blood by ELISA temporal association of anti-nephrin with clinical remission of nephrotic syndrome up to 12 months
Secondary 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
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