Chronic Kidney Disease, Receiving DialysisNCT01890577
Study of South African Dialysis Patients
An observational study of Chronic Kidney Disease, Receiving Dialysis, run by Amgen at 7 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Kidney Disease, Receiving Dialysis
- What is being tested?
- Aranesp
- How many people
- 28 participants
- Where
- 7 sitesSouth Africa
- Study dates
- Apr 2013to Jan 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving dialyis at South African study centres and having received at least one dose of Aranesp
Who may be able to join
- 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
Who cannot join
- Received Aranesp in an interventional study within 6 months prior to start of observation period
- Receive investigational product during the observation period
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Africa7 sites
Research Site
Cape Town, Western Cape, 7800
Research Site
Durban, 4001
Research Site
Glenwood, KwaZulu-Natal, 4083
Research Site
Kimberley, 8300
Research Site
Lenasia, 1821
Research Site
Roodepoort, 1709
Research Site
Umhlanga, KwaZulu-Natal, 4320
About this study
Official title: An Observational Study of South African Dialysis Patients Treated With Aranesp
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.
Read the 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.
- Being tested
- Aranesp
- Keywords
- Chronic kidney disease, Dialysis, Erythropoiesis stimulating agent, South Africa
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AranespDrug
Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Single cohort of dialysis patients Receives: Drug: Aranesp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin Concentration
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Each 4-week period for the duration of the study period (15 months)
Secondary outcomes (9)
Hemoglobin Excursions
Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Over the 15-month observation period
Hemoglobin Within the Range 10-12 g/dL Over Time
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: On a continuous basis over the 15-month observation period
Erythropoiesis Stimulating Agent (ESA) Usage
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Over the 15-month observation period
ESA/Aranesp Dose Ratio
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.
Measured: Day of commencement of Aranesp
Iron Therapy Use
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Over the 15-month observation period
Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: At each 12-week interval over the observation period
C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Over the 15-month observation period
Number of Red Blood Cell Transfusions
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Over the 15-month observation period
Number of Hospitalisations
Due to the premature termination of the study no outcome measure data were analyzed.
Measured: Over the 15-month observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Study was terminated due to slow enrolment with no reasonable expectation of attaining a meaningful sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease, Receiving DialysisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890577
- Sponsor's protocol ID
- 20110243
- Status last verified
- Jun 2016
- First submitted
- 18 Apr 2013
- Last updated
- 12 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of South African Dialysis Patients Treated With Aranesp
- ClinicalTrials.gov ID
- NCT01890577
- Acronym / sponsor ID
- 20110243
- Keywords
- Chronic kidney disease, Dialysis, Erythropoiesis stimulating agent, South Africa
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to slow enrolment with no reasonable expectation of attaining a meaningful sample size
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Posted 13 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Drug: AranespSingle cohort of dialysis patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving dialyis at South African study centres and having received at least one dose of Aranesp
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Received Aranesp in an interventional study within 6 months prior to start of observation period
- Receive investigational product during the observation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AranespObservational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice. | Drug | Study population |
Primary outcome
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.
9 secondary outcomes
Hemoglobin Excursions
Time frame: Over the 15-month observation period
Hemoglobin Within the Range 10-12 g/dL Over Time
Time frame: On a continuous basis over the 15-month observation period
Erythropoiesis Stimulating Agent (ESA) Usage
Time frame: Over the 15-month observation period
ESA/Aranesp Dose Ratio
Time frame: Day of commencement of Aranesp
Iron Therapy Use
Time frame: Over the 15-month observation period
Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy
Time frame: At each 12-week interval over the observation period
C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration
Time frame: Over the 15-month observation period
Number of Red Blood Cell Transfusions
Time frame: Over the 15-month observation period
Number of Hospitalisations
Time frame: Over the 15-month observation period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, Receiving Dialysis, run by Amgen at 7 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin Concentration (time frame: Each 4-week period for the duration of the study period (15 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.