Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease

January 29, 2019 updated by: Chow Kai Ming, Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Erythropoiesis-stimulating agent (ESA) has been commonly used to manage patients with end-stage renal disease receiving dialysis. The effects of ESA, however, are unclear. This study compares the result of erythropoiesis-stimulating agent (ESA) versus supportive care for chronic kidney disease patients receiving palliative care. The investigators design a retrospective 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. The primary objective is to assess whether ESA can reduce the transfusion burden and hospitalization.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong, SAR
        • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients who had dialysis or kidney transplant treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Chronic kidney disease patient receiving palliative care and erythropoiesis-stimulating agent
Drug: Erythropoiesis-Stimulating Agent
erythropoiesis-stimulating agent: Mircera or Darbepoietin
Control Group
Chronic kidney disease patient receiving palliative care without erythropoiesis-stimulating agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of red cell transfusion
Time Frame: one year
one year
days of hospitalisation
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

February 3, 2018

First Submitted That Met QC Criteria

February 3, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC2017.147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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