Actively Recruiting

Age: 0 - 75Years
All Genders
ID06162546

ARREST-NEPHROSIS - Austrian Resistant Nephrotic Syndrome Treatment Response Registry and Biobank

Led by Christoph Aufricht · Updated on 2023-12-08

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Nephrotic syndrome includes a group of kidney diseases causing protein loss in urine, blood protein abnormalities, fluid buildup, and kidney function problems. This research focuses on patients with resistant nephrotic syndrome, especially those with a condition called focal segmental glomerulosclerosis (FSGS), which can lead to kidney failure. The study aims to collect real-world data, connect patients and clinicians, recruit participants for future research, and build a biobank for studying biomarkers and disease progression. Participants who meet certain criteria, such as resistance to standard immunosuppressive treatments, specific protein levels in urine, and sufficient kidney function, will be invited to join the ARREST-NEPHROSIS registry. They will provide clinical information and samples to support research on resistant nephrotic syndrome. The registry supports long-term data collection to better understand treatment responses and disease outcomes. During the study, participants will undergo regular clinical assessments and contribute data about their health, treatments, and kidney function. Researchers will monitor proteinuria levels and kidney performance over time, including patient-reported outcomes. The study will last up to 20 years, allowing for continuous observation and networking among patients, families, and healthcare providers to improve future care and research opportunities.

CONDITIONS

Brief Title

ARREST-NEPHROSIS - Austrian Resistant Nephrotic Syndrome Treatment Response Registry and Biobank

Who Can Participate

Age: 0 - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Resistant to standard immunosuppressive agents (if clinically indicated, e.g. primary/non-genetic forms)
  • Persistent urinary protein-to-creatinine (UP/C) ratio greater than 1.0 g/g
  • Estimated glomerular filtration rate (eGFR) greater than 30 ml/min per 1.73 m2
  • Biopsy or a disease-causing genetic mutation associated with nephrotic syndrome
Not Eligible

You will not qualify if you...

  • Inability or unwillingness to comply with repeated assessments
  • Objections against participation at discretion of the investigator
  • Secondary nephrotic syndrome
  • Patients with steroid-dependence or frequently relapsing disease (but achievement of complete remission)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 20 years

Participants who undergo routine care are observed with continuous prospective assessment of clinical and patient-reported outcomes, including proteinuria and kidney function.

Regular visits according to routine clinical practice; frequency varies by participant

Trial Site Locations

Total: 1 location

1

Division of Pediatric Nephrology and Gastroenterology, Department of Pediatrics and Adolescent Medicine, Comprehensive Center for Pediatrics, Medical University of Vienna, 1090 Vienna, Austria.

Vienna, Austria, 1090

Actively Recruiting

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Research Team

C

Christoph Aufricht, Prof. MD

L

Lisa Daniel-Fischer, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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