NCT03427801

Brief Summary

An observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

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

Study Start

First participant enrolled

March 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

February 3, 2018

Last Update Submit

January 29, 2019

Conditions

Anemia of Chronic Kidney Disease

Keywords

erythropoiesis-stimulating agent

Outcome Measures

Primary Outcomes (2)

  • number of red cell transfusion

    one year

  • days of hospitalisation

    one year

Study Arms (2)

Treatment Group

Chronic kidney disease patient receiving palliative care and erythropoiesis-stimulating agent

Drug: Erythropoiesis-Stimulating Agent

Control Group

Chronic kidney disease patient receiving palliative care without erythropoiesis-stimulating agent

Interventions

Erythropoiesis-Stimulating AgentDRUG

erythropoiesis-stimulating agent: Mircera or Darbepoietin

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients with stage 4 to 5 chronic kidney disease undergoing palliative care pathway

You may qualify if:

  • patients aged 18 years and older, who opted for ESA treatment during palliative renal care for \> 360 days between January 1, 2014 and December 31, 2016

You may not qualify if:

  • patients who had dialysis or kidney transplant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, SAR, Hong Kong

Location

MeSH Terms

Interventions

Hematinics

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 3, 2018

First Posted

February 9, 2018

Study Start

March 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)