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Study of South African Dialysis Patients

This study has been terminated.
(Study was terminated due to slow enrolment with no reasonable expectation of attaining a meaningful sample size)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01890577
First Posted: July 2, 2013
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  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: Each 4-week period for the duration of the study period (15 months) ]
    Due to the premature termination of the study no outcome measure data were analyzed.


Secondary Outcome Measures:
  • Hemoglobin Excursions [ Time Frame: Over the 15-month observation period ]
    Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.

  • Hemoglobin Within the Range 10-12 g/dL Over Time [ Time Frame: On a continuous basis over the 15-month observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.

  • Erythropoiesis Stimulating Agent (ESA) Usage [ Time Frame: Over the 15-month observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.

  • ESA/Aranesp Dose Ratio [ Time Frame: Day of commencement of Aranesp ]

    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. Not applicable to participants who were ESA-naive at time of Aranesp commencement.

    Due to the premature termination of the study no outcome measure data were analyzed.


  • Iron Therapy Use [ Time Frame: Over the 15-month observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.

  • Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy [ Time Frame: At each 12-week interval over the observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.

  • C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration [ Time Frame: Over the 15-month observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.

  • Number of Red Blood Cell Transfusions [ Time Frame: Over the 15-month observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.

  • Number of Hospitalisations [ Time Frame: Over the 15-month observation period ]
    Due to the premature termination of the study no outcome measure data were analyzed.


Enrollment: 28
Study Start Date: April 2013
Study Completion Date: January 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01890577     History of Changes
Other Study ID Numbers: 20110243
First Submitted: April 18, 2013
First Posted: July 2, 2013
Results First Submitted: March 31, 2015
Results First Posted: April 13, 2015
Last Update Posted: July 12, 2016
Last Verified: June 2016

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics