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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Associated Anemia
• Intervention / Treatment: Other: Non-Interventional

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 14415

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • SE46001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prevalent population of CKD patients > 18 years in the Swedish Renal Registry in 2015 both dependent on dialysis (DD) and not on dialysis (ND); the main analyses will be conducted on patients receiving treatment for renal anaemia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Non-Interventional; 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.	Other: Non-Interventional; Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population	Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.	1 year (data from 2015)
Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population	Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.	1 year (data from 2015)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)	The proportion of ND patients on low, normal and high dose ESA will be calculated.	1 year (data from 2015)
Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA	The proportion of DD patients on low, normal and high dose ESA will be calculated.	1 year (data from 2015)
ESA use in ND patients at each CKD stage	The number of ND patients using/not using ESA at each CKD stage.	1 year (data from 2015)
ESA use in DD patients	The number of DD patients using/not using ESA.	1 year (data from 2015)
Proportion of ND patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron	Proportion of ND patients treated with ESAs in each CKD stage with or without oral/iv iron.	1 year (data from 2015)
Proportion of DD patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron	Proportion of DD patients treated with ESAs in each CKD stage with or without oral/iv iron.	1 year (data from 2015)
Proportion of ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range	Proportion of ND patients within pre-specified Hb target.	1 year (data from 2015)
Proportion of ESA treated DD patients within Haemoglobin (Hb) levels within pre-specified target range	Proportion of DD patients within pre-specified Hb target.	1 year (data from 2015)
Proportion of ND patients with anemia who are not treated with ESAs	Proportion of ND patients with anemia not treated with ESAs.	1 year (data from 2015)
Proportion of DD patients with anemia who are not treated with ESAs	Proportion of DD patients with anemia not treated with ESAs.	1 year (data from 2015)
Proportion of ESA treated ND patients with low or medium and high C-reactive protein (CRP)	Proportion of ND patients with low, medium or high CRP.	1 year (data from 2015)
Proportion of ESA treated DD patients with low or medium and high CRP	Proportion of DD patients with low, medium or high CRP.	1 year (data from 2015)
Proportion of ESA treated ND patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations	Proportion of ESA treated ND patients with hyperlipidemia High density lipoprotein / Low density lipoprotein (HDL/LDL) and/or taking lipid lowering drugs.	1 year (data from 2015)
Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations	Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering drugs.	1 year (data from 2015)
Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive medication	Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive drugs.	1 year (data from 2015)
Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive medication	Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive drugs.	1 year (data from 2015)
Number of ND patients with serious cardiovascular events	The number of ND patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.	4 years (CV events may be compared from data covering 2012 to 2016)
Number of DD patients with serious cardiovascular events	The number of DD patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.	4 years (CV events may be compared from data covering 2012 to 2016)
Number of ND patients with serious thromboembolic events	The number of ND patients with serious thromboembolic events (i.e. stroke) will be evaluated.	1 year (data from 2015)
Number of DD patients with serious thromboembolic events	The number of DD patients with serious thromboembolic events (i.e. stroke) will be evaluated.	1 year (data from 2015)
All cause mortality: ND	The number of deaths in the ND population.	1 year (data from 2015)
All cause mortality: DD	The number of deaths in the DD population.	1 year (data from 2015)
Correlation between ESA dose and Hb level in relation to CKD severity (stage 3,4, 5 and DD)	Scatter plots of ESA dose against hemoglobin level for CKD severity (stage 3, 4, 5 and DD).	1 year (data from 2015)
Correlation between Haemoglobin (Hb) level and CKD severity: ND	Box plots of ESA dose against CKD severity (stage 3,4, 5).	1 year (data from 2015)
Correlation between ESA dose and C-reactive protein (CRP) level: ND	Scatter plot of ESA dose versus CRP level in ND population.	1 year (data from 2015)
Correlation between ESA dose and CRP level: DD	Scatter plot of ESA dose versus CRP level in DD population.	1 year (data from 2015)
Relationship between ESA dose and occurrence of Cardiovascular (CV) events in ND population	Box plot of ESA dose in ND patients with or without CV events.	1 year (data from 2015)
Relationship between Hb level and occurrence of CV events in ND population	Box plot of Hb level in ND patients with or without CV events.	1 year (data from 2015)
Relationship between Hb level and occurrence of CV events in DD population	Box plot of Hb level in DD patients with or without CV events.	1 year (data from 2015)

Collaborators and Investigators

• Sponsor: Astellas Pharma a/s
• Investigators: Study Chair: Medical Advisor, Astellas Pharma a/s

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: erythropoiesis stimulating agent; ASP1517; chronic kidney disease associated anemia
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia
• Other Study ID Numbers: 1517-MA-3139-SN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual patient level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Information for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No