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

NCT06162546 | Recruiting

• 1 other identifier: ARREST-NEPHROSIS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Nephrotic syndrome is the clinical phenotype of a heterogeneous group of glomerular diseases that may present with varying degrees of urinary protein loss (proteinuria), dysproteinemia in the blood, fluid retention and impaired renal function. The AustRian RESistanT NEPHROtic Syndrome Treatment Response RegIStry and Biobank (ARREST-NEPHROSIS) sets out to achieve the following goals, as typical categories of rare disease registries

1. 1.Obtaining real world data on practice patterns and outcomes
2. 2.Networking between affected patients, families, and clinicians.
3. 3.Establish a patient base for facilitated recruitment in studies of drugs, medical devices, and products
4. 4.Development of a Biobank to enable research of potential biomarkers and therapy or disease courses

Conditions

Focal Segmental Glomerulosclerosis; Proteinuria; Nephrotic Syndrome; Nephrotic Syndrome Steroid-Resistant

Outcome Measures

Primary Outcomes (4)

• Obtaining real world data on practice patterns and outcomes in resistant nephrotic syndrome

  up to 20 years

• Enable networking between patients, families, and clinicians affected by resistant nephrotic syndrome

  up to 20 years

• Establish a patient base for facilitated recruitment in studies of drugs, medical devices, and products on resistant nephrotic syndrome

  up to 20 years

• Development of a Biobank to enable research of potential biomarkers and therapy or disease courses

  up to 20 years

Study Arms (1)

ARREST NEPHROSIS Participants

Other: Registry

Interventions

Registry OTHER

Registry Participation, providing data and clinical specimen

ARREST NEPHROSIS Participants

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with nephrotic syndrome are informed about the project as part of a routine check-up and invited to participate by their treating physician. Patients are also informed verbally that there is no obligation to participate and that they can withdraw their willingness to participate at any time.

You may qualify if:

• Resistant to standard Immunosuppressive agents (if clinically indicated, e.g. primary/non-genetic forms)
• Persistent urinary protein-to-creatinine (UP/C) ratio \>1.0 g/g
• eGFR \> 30 ml/min per 1.73 m2
• biopsy or a disease-causing genetic mutation associated with nephrotic syndrome

You may not qualify if:

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

Sponsors & Collaborators

• Christoph Aufricht: lead

Study Sites (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, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Proteinuria; Nephrotic Syndrome

Interventions

Registries

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nephrosis

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Christoph Aufricht, Prof. MD

CONTACT

+4314040021115; christoph.aufricht@meduniwien.ac.at

Lisa Daniel-Fischer, MD

CONTACT

+4314040021115; lisa.daniel-fischer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)