Terminated/Withdrawn
Sponsor ID
20110243

Study of South African Dialysis Patients

Sponsor ID
20110243
Clinicaltrials.gov ID
NCT01890577
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
N/A
Product
darbepoetin alfa
Type
Observational
Masking
N/A
Enrollment
28
Additional Study Details

Protocol Summary

Primary Outcome Measures

Haemoglobin concentration

Timeframe: Reported as the mean of all available values for each 4-week period for the duration of the individual study period

Secondary Outcome Measures

Haemoglobin excursions

Timeframe: On a continuous basis over individual 15-month observation period up

Haemoglobin within range

Timeframe: On a continuous basis over individual 15-month observation period

Erythropoiesis stimulating agent (ESA) usage

Timeframe: On a continuous basis over individual 15-month observation period

ESA/Aranesp dose ratio

Timeframe: Day of commencement of Aranesp

Iron therapy use

Timeframe: On a continuous basis over individual 15-month observation period

Use of concomitant therapies: Immunosuppressants, cardiovascular medications, secondary hypoparathyroidism medications, anti-retroviral therapy

Timeframe: Usage recorded at each 12-week interval over the individual observation period

C-Reactive protein, albumin, transferrin saturation and serum ferritin

Timeframe: As available over individual 15-month observation period

Red cell transfusions

Timeframe: As occurring over individual 15-month observation period

Hospitalisation

Timeframe: As occurring over individual 15-month observation period

ESA usage

Timeframe: On a continuous basis over individual 15-month observation period

Iron therapy use

Timeframe: On a continuous basis over individual 15-month observation period

Iron therapy use

Timeframe: On a continuous basis over individual 15-month observation period

Iron therapy use

Timeframe: On a continuous basis over individual 15-month observation period

ESA usage

Timeframe: On a continuous basis over individual 15-month observation period

Red cell transfusions

Timeframe: As occurring over individual 15-month observation period

Hospitalisation

Timeframe: As occurring over individual 15-month observation period

Hospitalisation

Timeframe: As occurring over individual 15-month observation period

Locations

Location
Status
Contact Us
Location
Research Site
Cape Town, Western Cape, South Africa, 7800
Status
Completed
Location
Research Site
Durban, South Africa, 4001
Status
Completed
Location
Research Site
Glenwood, KwaZulu-Natal, South Africa, 4083
Status
Completed
Location
Research Site
Kimberley, South Africa, 8300
Status
Completed
Location
Research Site
Lenasia, South Africa, 1821
Status
Completed
Location
Research Site
Roodepoort, South Africa, 1709
Status
Completed
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