Study of South African Dialysis Patients

This study has been terminated.
(Administrative Decision by Amgen)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01890577
First received: April 18, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Chronic Kidney Disease, Receiving Dialysis
Drug: Aranesp

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of South African Dialysis Patients Treated With Aranesp

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Haemoglobin concentration [ Time Frame: Reported as the mean of all available values for each 4-week period for the duration of the individual study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Haemoglobin excursions [ Time Frame: On a continuous basis over individual 15-month observation period up ] [ Designated as safety issue: No ]
    Hb <10g/dL ; Hb >12g/dL

  • Haemoglobin within range [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Hb 10-12g/dL

  • Erythropoiesis stimulating agent (ESA) usage [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Type

  • ESA/Aranesp dose ratio [ Time Frame: Day of commencement of Aranesp ] [ Designated as safety issue: No ]
    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. This secondary outcome measure is not applicable to subjects who are ESA-naive at time of Aranesp commencement.

  • Iron therapy use [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Dose

  • Use of concomitant therapies: Immunosuppressants, cardiovascular medications, secondary hypoparathyroidism medications, anti-retroviral therapy [ Time Frame: Usage recorded at each 12-week interval over the individual observation period ] [ Designated as safety issue: No ]
    Type

  • C-Reactive protein, albumin, transferrin saturation and serum ferritin [ Time Frame: As available over individual 15-month observation period ] [ Designated as safety issue: No ]
    Concentration

  • Red cell transfusions [ Time Frame: As occurring over individual 15-month observation period ] [ Designated as safety issue: No ]
    Number of red cell transfusions

  • Hospitalisation [ Time Frame: As occurring over individual 15-month observation period ] [ Designated as safety issue: No ]
    Dates and duration of hospital admissions

  • ESA usage [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Dose

  • Iron therapy use [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Type

  • Iron therapy use [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Dosing frequency

  • Iron therapy use [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Route of administration

  • ESA usage [ Time Frame: On a continuous basis over individual 15-month observation period ] [ Designated as safety issue: No ]
    Dosing frequency

  • Red cell transfusions [ Time Frame: As occurring over individual 15-month observation period ] [ Designated as safety issue: No ]
    Number of units transfused

  • Hospitalisation [ Time Frame: As occurring over individual 15-month observation period ] [ Designated as safety issue: No ]
    Number of days spent in Intensive Care Unit

  • Hospitalisation [ Time Frame: As occurring over individual 15-month observation period ] [ Designated as safety issue: No ]
    Primary reason for admission; final diagnosis


Enrollment: 32
Study Start Date: April 2013
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study population
Single cohort of dialysis patients
Drug: Aranesp
Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890577

Locations
South Africa
Research Site
Glenwood, KwaZulu-Natal, South Africa, 4083
Research Site
Umhlanga Rocks, KwaZulu-Natal, South Africa, 4320
Research Site
Cape Town, Western Cape, South Africa, 7800
Research Site
Durban, South Africa, 4001
Research Site
Kimberley, South Africa, 8300
Research Site
Lenasia, South Africa, 1821
Research Site
Roodepoort, South Africa, 1709
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01890577     History of Changes
Other Study ID Numbers: 20110243
Study First Received: April 18, 2013
Last Updated: April 9, 2014
Health Authority: South Africa: Medicines Control Council

Keywords provided by Amgen:
Chronic kidney disease
Dialysis
Erythropoiesis stimulating agent
South Africa

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014