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Sex Differences in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03771703
Recruitment Status : Active, not recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Ass. Prof. Dr. Manfred Hecking, MD, Medical University of Vienna

Brief Summary:

Objectives 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. Description and analysis of sex-specific differences in hemodialysis patients and the associated male-to-female mortality in Austria.
  2. Description and analysis of sex-specific differences in treatment and outcomes in hospitalized patients with chronic kidney disease.
  3. Descriptive analysis of decision-making by doctors and patients with regard to hemodialysis initiation.

Condition or disease
Chronic Kidney Diseases

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Exploratory Study in Three Parts to Determine Sex-Specific Differences in Chronic Kidney Disease Recognition, Progression and Treatment
Actual Study Start Date : December 2, 2018
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Sex-specific mortality among incident patients undergoing hemodialysis [ Time Frame: Through study completion, the expected average follow-up being 4 years. ]
    "Incident" hemodialysis patients are all those who have entered the Dialysis Registry (they will constitute the study population).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
as specified in the detailed study description
Criteria

Inclusion Criteria:

  • Austrian Dialysis Registry Patient or outpatient

Exclusion Criteria:

  • Not an Austrian Dialysis Registry Patient or not an outpatient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771703


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Ass. Prof. Dr. Manfred Hecking, MD
Karolinska Institutet
Investigators
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Study Director: Rainer Oberbauer, MD Medical University of Vienna
  Study Documents (Full-Text)

Documents provided by Ass. Prof. Dr. Manfred Hecking, MD, Medical University of Vienna:

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Responsible Party: Ass. Prof. Dr. Manfred Hecking, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03771703     History of Changes
Other Study ID Numbers: EK Nr. 1363/2016
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency