Study of South African Dialysis Patients

Study Overview
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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.

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.

Official Title
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An Observational Study of South African Dialysis Patients Treated With Aranesp

Conditions
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Chronic Kidney Disease, Receiving Dialysis

Intervention / Treatment
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* Drug: Aranesp


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Single cohort of dialysis patients | Drug: Aranesp<br>* Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin Concentration | 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 | 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 | 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 | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | 
| ESA/Aranesp Dose Ratio | 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 | 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 | 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 | 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 | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | 
| Number of Hospitalisations | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Chronic kidney disease, Erythropoiesis stimulating agent, South Africa