Study of South African Dialysis Patients

June 8, 2016 updated by: Amgen

An Observational Study of South African Dialysis Patients Treated With Aranesp

An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This multicentre, prospective, observational study will describe the treatment and clinical outcomes of of dialysis patients in South Africa. No formal hypothesis will be tested in this descriptive study. Eligible subjects will be receiving either peritoneal or haemodialysis, will have received Aranesp therapy between 3 and 6 months prior to enrolment into the study, do not need to be receiving Aranesp at the time of enrolment and will be followed for up to 12 months after commencement of Aranesp. Data to be collected includes ESA therapies, iron usage, relevant concomitant therapies, haemoglobin concentrations, other relevant clinical laboratory parameters and red cell transfusions.

Study Type

Observational

Enrollment (Actual)

28

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

  • South Africa
      • Durban, South Africa, 4001
        • Research Site
      • Kimberley, South Africa, 8300
        • Research Site
      • Lenasia, South Africa, 1821
        • Research Site
      • Roodepoort, South Africa, 1709
        • Research Site
    • KwaZulu-Natal
      • Glenwood, KwaZulu-Natal, South Africa, 4083
        • Research Site
      • Umhlanga Rocks, KwaZulu-Natal, South Africa, 4320
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7800
        • Research Site

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients receiving dialyis at South African study centres and having received at least one dose of Aranesp

Description

Inclusion Criteria:

  • Adult patients undergoing chronic haemodialysis or peritoneal dialysis
  • Commenced Aranesp therapy 3-6 months prior to enrolment
  • Erythropoiesis stimulating agent (ESA) naive or treated with another ESA prior to commencing Aranesp
  • Informed consent obtained

Exclusion Criteria:

  • Received Aranesp in an interventional study within 6 months prior to start of observation period
  • Receive investigational product during the observation period

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
Study population
Single cohort of dialysis patients
Drug: Aranesp
Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemoglobin Concentration
Time Frame: Each 4-week period for the duration of the study period (15 months)
Due to the premature termination of the study no outcome measure data were analyzed.
Each 4-week period for the duration of the study period (15 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Excursions
Time Frame: Over the 15-month observation period
Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.
Over the 15-month observation period
Hemoglobin Within the Range 10-12 g/dL Over Time
Time Frame: On a continuous basis over the 15-month observation period
Due to the premature termination of the study no outcome measure data were analyzed.
On a continuous basis over the 15-month observation period
Erythropoiesis Stimulating Agent (ESA) Usage
Time Frame: Over the 15-month observation period
Due to the premature termination of the study no outcome measure data were analyzed.
Over the 15-month observation period
ESA/Aranesp Dose Ratio
Time Frame: Day of commencement of Aranesp

Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement.

Due to the premature termination of the study no outcome measure data were analyzed.
Day of commencement of Aranesp
Iron Therapy Use
Time Frame: Over the 15-month observation period
Due to the premature termination of the study no outcome measure data were analyzed.
Over the 15-month observation period
Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy
Time Frame: At each 12-week interval over the observation period
Due to the premature termination of the study no outcome measure data were analyzed.
At each 12-week interval over the observation period
C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration
Time Frame: Over the 15-month observation period
Due to the premature termination of the study no outcome measure data were analyzed.
Over the 15-month observation period
Number of Red Blood Cell Transfusions
Time Frame: Over the 15-month observation period
Due to the premature termination of the study no outcome measure data were analyzed.
Over the 15-month observation period
Number of Hospitalisations
Time Frame: Over the 15-month observation period
Due to the premature termination of the study no outcome measure data were analyzed.
Over the 15-month observation period

Collaborators and Investigators

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

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 2, 2013

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110243

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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