A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease

NCT ID: NCT03643601

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14415 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-24

Study Completion Date

2018-12-04

Brief Summary

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The primary purpose of this study is to describe renal anemia treatment patterns in non-dialysis dependent (ND) and dialysis dependent (DD) populations, with a particular focus on iron use in erythropoiesis stimulating agent (ESA) treated patients.

This study will also provide an epidemiological description of chronic kidney disease (CKD) associated anemia in relation to CKD stage, dialysis modality and underlying morbidity, as well as describe the relationship between inflammation and ESA treatment and describe the associated cardiovascular illness in ESA treated patients.

Detailed Description

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Data from year 2015 will be used for the prevalence analysis.The prevalent population of CKD patients \> 18 years in the Swedish Renal Registry in 2015 both dependent on dialysis (DD) and not on dialysis (ND).

Conditions

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Chronic Kidney Disease Associated Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-Dialysis (ND) Patients

For the ND patients, data are captured on each clinic visit during the course of the year (2-4 times per year), the last available record for 2015 will be used.

Non-Interventional

Intervention Type OTHER

Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs

Dialysis (DD) Patients

For the DD patients, data are input from a randomly selected visit to the hospital in September to October 2015; the evaluation will be based on this record.

Non-Interventional

Intervention Type OTHER

Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs

Interventions

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Non-Interventional

Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* For ND-CKD population:

* all prevalent patients with a CKD with Estimated Glomerular filtration rate (eGFR) \< 45ml/min/1.73m2 with a recorded visit pre-dialysis in Swedish Renal Registry (SRR) in 2015
* Not on dialysis
* For DD-CKD population

* All prevalent patients taking part in the yearly cross-sectional dialysis investigation in SRR in 2015
* Dialysis dependent

Exclusion Criteria

* not applicable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma a/s

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Advisor

Role: STUDY_CHAIR

Astellas Pharma a/s

Locations

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SE46001

Stockholm, , Sweden

Site Status

Countries

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Sweden

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=352

Link to results on Astellas Clinical Study Results website

Other Identifiers

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1517-MA-3139-SN

Identifier Type: -

Identifier Source: org_study_id

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