Sex Differences in Chronic Kidney Disease

NCT03771703 | Unknown

• 1 other identifier: EK Nr. 1363/2016
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe sex specific differences of the hemodialysis population in Austria, to quantify sex specific differences in treatment and outcomes in hospitalized patients with chronic kidney disease and to examine decision making by doctors and patients with regards to hemodialysis initiation. To adequately serve the needs of these research questions, the study is divided into 3 parts (sub-studies).

1. 1.Description and analysis of sex-specific differences in renal replacement therapy in Austria.
2. 2.Description and analysis of the competing risks of death versus renal replacement therapy initiation in the chronic kidney disease population by sex.
3. 3.Analysis of sex differences in renal replacement therapy initiation decisions, emphasizing patient perception and socio-economic differences.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Sex-specific mortality among incident patients undergoing hemodialysis

  "Incident" hemodialysis patients are all those who have entered the Dialysis Registry (they will constitute the study population).

  Through study completion, the expected average follow-up being 4 years.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

as specified in the detailed study description

You may qualify if:

• Austrian Dialysis Registry Patient or outpatient
• Criteria for participation in the survey will be (i) a diagnosis of CKD (eGFR \<60 mL/min/1.73 m2) \[50% \<15\]) and (ii) appropriate language skills to fill in a survey.

You may not qualify if:

• Not an Austrian Dialysis Registry Patient or not an outpatient

Sponsors & Collaborators

• Assoc. Prof. Dr. Manfred Hecking, MD PhD: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rainer Oberbauer, MD

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 11, 2018
• Study Start: December 2, 2018
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)