Study of South African Dialysis Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease, Receiving Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

Single cohort of dialysis patients

Aranesp

Intervention Type DRUG

Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.

Interventions

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Aranesp

Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No