NCT03643601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

August 21, 2018

Last Update Submit

October 29, 2024

Conditions

Chronic Kidney Disease Associated Anemia

Keywords

erythropoiesis stimulating agentchronic kidney disease associated anemiaASP1517

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (29)

  • Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)

    1 year (data from 2015)

  • Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA

    1 year (data from 2015)

  • ESA use in ND patients at each CKD stage

    1 year (data from 2015)

  • ESA use in DD patients

    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

    1 year (data from 2015)

  • +24 more secondary outcomes

Study Arms (2)

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

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

Interventions

Non-InterventionalOTHER

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

Dialysis (DD) PatientsNon-Dialysis (ND) Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SE46001

Stockholm, Sweden

Location

Related Links

Study Officials

  • Medical Advisor

    Astellas Pharma a/s

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

September 24, 2018

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Locations

SE(1)