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NCT Number: NCT06315504

Circulating Factors in Nephrotic Syndrome

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Observation

Primary outcomes

  1. levels of anti-nephrin in blood by ELISA

    Time frame: up to 12 months

    temporal association of anti-nephrin with clinical remission of nephrotic syndrome

Secondary outcomes

  1. changes in auto-antibodies in blood associated with membranous nephropathy

    Time frame: up to 24 months

    temporal association of auto-antibodies with clinical remission of nephrotic syndrome

Study contacts

Contact information is provided by the study sponsor or research team.

Ditte Hansen, MD PhD

CONTACT

[email protected]

+4538682056

Iain Bressendorff, MD PhD

CONTACT

[email protected]

+4524277139

Sponsors and collaborators

Lead sponsor

Iain Bressendorff

Other

Registry information

Official study title

Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Mar 18, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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