Study of South African Dialysis Patients

Terminated

Conditions: Chronic Kidney Disease, Receiving Dialysis

Interventions: Drug: Aranesp

Registration Number: NCT01890577

Lead Sponsor: Amgen

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 28

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Aranesp	Single cohort of dialysis patients

Primary Outcome Measures

Name	Time	Method
Haemoglobin Concentration	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.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Excursions	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.
Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy	At each 12-week interval over the observation period	Due to the premature termination of the study no outcome measure data were analyzed.
Hemoglobin Within the Range 10-12 g/dL Over Time	On a continuous basis over the 15-month observation period	Due to the premature termination of the study no outcome measure data were analyzed.
ESA/Aranesp Dose Ratio	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.
Iron Therapy Use	Over the 15-month observation period	Due to the premature termination of the study no outcome measure data were analyzed.
Number of Hospitalisations	Over the 15-month observation period	Due to the premature termination of the study no outcome measure data were analyzed.
Erythropoiesis Stimulating Agent (ESA) Usage	Over the 15-month observation period	Due to the premature termination of the study no outcome measure data were analyzed.
Number of Red Blood Cell Transfusions	Over the 15-month observation period	Due to the premature termination of the study no outcome measure data were analyzed.
C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration	Over the 15-month observation period	Due to the premature termination of the study no outcome measure data were analyzed.