Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease

NCT01763242 | Completed Phase 4

• 1 other identifier: HREC: 2010.267
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Aims:

1. 1.To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).
2. 2.To compare this electronic process with "present anaemia management" in the traditional outpatient setting.
3. 3.To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.

Conditions

Kidney Failure, Chronic; Anemia

Keywords

CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery

Outcome Measures

Primary Outcomes (1)

• Haemoglobin

  Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.

  12 months

Secondary Outcomes (20)

• All Cause Hospitalisation

  12 months

• Outpatient Review Numbers

  12 months

• Primary Care review Numbers

  12 months

• Cardiovascular Hospitalisation

  12 months

• Cerebrovascular Hospitalisation

  12 months

Other Outcomes (1)

• Sub-Analysis of Outcomes by ESA Type

  12 months

Study Arms (2)

EMAN

ACTIVE COMPARATOR

Electronic auditing via synchronised blood tests and monthly dosing ESA and Home delivery of ESA from Pharmacy if required

Other: EMAN

Control

NO INTERVENTION

Standard Outpatient Care with usual blood tests and follow up, and varied ESA dosing and frequency times. Patients are responsible for collecting their own ESA from Pharmacy

Interventions

EMAN OTHER

See details on ESA Synchronization and Dosing in Detailed Description Above

Also known as: Synchronised Blood Testing, Electronic upload of Blood Results, Synchronised ESA dosing monthly, Home delivery of ESA

EMAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age \> 18 years
• Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria

You may not qualify if:

• Pregnancy
• Significant acute bleeding such as overt gastrointestinal bleeding
• A known haematological cause for anaemia
• Known metastatic malignancy
• Present participation in another interventional clinical trial • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

Sponsors & Collaborators

• Western Health, Australia: lead

Study Sites (1)

Western Health

Footscray, Victoria, 3011, Australia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Craig L Nelson, MBBSFRACPPhD

  Western Health, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit - Nephrology

Study Record Dates

• First Submitted: January 6, 2013
• First Posted: January 8, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

AU (1)