NCT01890577

Study of South African Dialysis Patients

An Observational Study of South African Dialysis Patients Treated With Aranesp

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease, Receiving Dialysis

Interventions

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

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-07-02
• Last updated: 2016-07-12
• Results posted: 2015-04-13

Locations

7 sites across 1 country: South Africa