Clinical trial NCT01890577: Study of South African Dialysis Patients
Official title: An Observational Study of South African Dialysis Patients Treated With Aranesp
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Kidney Disease, Receiving Dialysis
Keywords: Chronic kidney disease
Dialysis
Erythropoiesis stimulating agent
South Africa
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients receiving dialyis at South African study centres and having received at least one dose of Aranesp

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.

Eligibility criteria: 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

Primary outcomes:
measure: Haemoglobin Concentration
timeFrame: Each 4-week period for the duration of the study period (15 months)
Secondary outcomes:
measure: Hemoglobin Excursions
timeFrame: Over the 15-month observation period
measure: Hemoglobin Within the Range 10-12 g/dL Over Time
timeFrame: On a continuous basis over the 15-month observation period
measure: Erythropoiesis Stimulating Agent (ESA) Usage
timeFrame: Over the 15-month observation period
measure: ESA/Aranesp Dose Ratio
timeFrame: Day of commencement of Aranesp
measure: Iron Therapy Use
timeFrame: Over the 15-month observation period
measure: Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy
timeFrame: At each 12-week interval over the observation period
measure: C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration
timeFrame: Over the 15-month observation period
measure: Number of Red Blood Cell Transfusions
timeFrame: Over the 15-month observation period
measure: Number of Hospitalisations
timeFrame: Over the 15-month observation period
Other outcomes:
Locations:
city: Glenwood
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Umhlanga Rocks
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Durban
country: South Africa
facility: Research Site
city: Kimberley
country: South Africa
facility: Research Site
city: Lenasia
country: South Africa
facility: Research Site
city: Roodepoort
country: South Africa
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: