Effect of Erythropoiesis-Stimulating Agent Therapy in Pat... | NCT03427801

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

NCT03427801

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jan 31, 2019Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Anemia of Chronic Kidney Disease

Interventions

Erythropoiesis-Stimulating Agent

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Feb 3, 2018

First Submission Date that Met QC Criteria

Feb 3, 2018

First Posted Date

Feb 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2019

Last Update Posted Date

Jan 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Erythropoiesis-Stimulating Agent	Drug	erythropoiesis-stimulating agent: Mircera or Darbepoietin	Treatment Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital, Chinese University of Hong Kong		Shatin	New Territories	SAR	Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006397	Hematinics

Ancestor Terms

ID	Term
D006401	Hematologic Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided