Chronic Kidney Disease Associated Anemia Clinical Trial
— ASKOfficial title:
A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)
| Verified date | December 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 14415 |
| Est. completion date | December 4, 2018 |
| Est. primary completion date | December 4, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | SE46001 | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma a/s |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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 | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | ESA use in DD patients | The number of DD patients using/not using ESA. | 1 year (data from 2015) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | All cause mortality: ND | The number of deaths in the ND population. | 1 year (data from 2015) | |
| Secondary | All cause mortality: DD | The number of deaths in the DD population. | 1 year (data from 2015) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Correlation between ESA dose and CRP level: DD | Scatter plot of ESA dose versus CRP level in DD population. | 1 year (data from 2015) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) |