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.
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
28
Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.
Research Site
Glenwood, KwaZulu-Natal, South Africa
Research Site
Umhlanga, KwaZulu-Natal, South Africa
Research Site
Cape Town, Western Cape, South Africa
Research Site
Durban, South Africa
Haemoglobin Concentration
Due to the premature termination of the study no outcome measure data were analyzed.
Time frame: Each 4-week period for the duration of the study period (15 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day of commencement of Aranesp
Iron Therapy Use
Due to the premature termination of the study no outcome measure data were analyzed.
Time frame: Over the 15-month observation period
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Research Site
Kimberley, South Africa
Research Site
Lenasia, South Africa
Research Site
Roodepoort, South Africa
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.
Time frame: 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.
Time frame: 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.
Time frame: Over the 15-month observation period
Number of Hospitalisations
Due to the premature termination of the study no outcome measure data were analyzed.
Time frame: Over the 15-month observation period