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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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