Study of South African Dialysis Patients

Amgen

Status: Terminated

Conditions: Chronic Kidney Disease, Receiving Dialysis

Treatments: Drug: Aranesp

Study type: Observational

Funder types: Industry

Identifiers

NCT01890577

20110243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Study population

Description:

Single cohort of dialysis patients

Treatment:

Drug: Aranesp