Clinical trial NCT03643601: A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease
Official title: A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease Associated Anemia
Keywords: erythropoiesis stimulating agent
chronic kidney disease associated anemia
ASP1517
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 14415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population
timeFrame: 1 year (data from 2015)
measure: Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population
timeFrame: 1 year (data from 2015)
Secondary outcomes:
measure: Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)
timeFrame: 1 year (data from 2015)
measure: Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA
timeFrame: 1 year (data from 2015)
measure: ESA use in ND patients at each CKD stage
timeFrame: 1 year (data from 2015)
measure: ESA use in DD patients
timeFrame: 1 year (data from 2015)
measure: Proportion of ND patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron
timeFrame: 1 year (data from 2015)
measure: Proportion of DD patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated DD patients within Haemoglobin (Hb) levels within pre-specified target range
timeFrame: 1 year (data from 2015)
measure: Proportion of ND patients with anemia who are not treated with ESAs
timeFrame: 1 year (data from 2015)
measure: Proportion of DD patients with anemia who are not treated with ESAs
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated ND patients with low or medium and high C-reactive protein (CRP)
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated DD patients with low or medium and high CRP
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated ND patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive medication
timeFrame: 1 year (data from 2015)
measure: Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive medication
timeFrame: 1 year (data from 2015)
measure: Number of ND patients with serious cardiovascular events
timeFrame: 4 years (CV events may be compared from data covering 2012 to 2016)
measure: Number of DD patients with serious cardiovascular events
timeFrame: 4 years (CV events may be compared from data covering 2012 to 2016)
measure: Number of ND patients with serious thromboembolic events
timeFrame: 1 year (data from 2015)
measure: Number of DD patients with serious thromboembolic events
timeFrame: 1 year (data from 2015)
measure: All cause mortality: ND
timeFrame: 1 year (data from 2015)
measure: All cause mortality: DD
timeFrame: 1 year (data from 2015)
measure: Correlation between ESA dose and Hb level in relation to CKD severity (stage 3,4, 5 and DD)
timeFrame: 1 year (data from 2015)
measure: Correlation between Haemoglobin (Hb) level and CKD severity: ND
timeFrame: 1 year (data from 2015)
measure: Correlation between ESA dose and C-reactive protein (CRP) level: ND
timeFrame: 1 year (data from 2015)
measure: Correlation between ESA dose and CRP level: DD
timeFrame: 1 year (data from 2015)
measure: Relationship between ESA dose and occurrence of Cardiovascular (CV) events in ND population
timeFrame: 1 year (data from 2015)
measure: Relationship between Hb level and occurrence of CV events in ND population
timeFrame: 1 year (data from 2015)
measure: Relationship between Hb level and occurrence of CV events in DD population
timeFrame: 1 year (data from 2015)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: SE46001
Study officials:
affiliation: Astellas Pharma a/s
name: Medical Advisor
role: STUDY_CHAIR
References: