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Study was terminated due to slow enrolment with no reasonable expectation of attaining a meaningful sample size
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Single cohort of dialysis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aranesp | Drug | Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin Concentration | Due to the premature termination of the study no outcome measure data were analyzed. | Each 4-week period for the duration of the study period (15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over the 15-month observation period |
| Hemoglobin Within the Range 10-12 g/dL Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients receiving dialyis at South African study centres and having received at least one dose of Aranesp
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glenwood | KwaZulu-Natal | 4083 | South Africa | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aranesp® | Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Full Analysis Set (FAS) consists of all patients enrolled into the study after commencing Aranesp® therapy amd with reported data
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| ID | Title | Description |
|---|---|---|
| BG000 | Aranesp® | Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were available for 27 participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Haemoglobin Concentration | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | Each 4-week period for the duration of the study period (15 months) |
|
|
15 months
Only serious and non-serious adverse drug reactions which in the Investigator's opinion are causally related to Aranesp were collected during this observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aranesp® | Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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Due to the premature termination of the study no outcome measure data were analyzed. |
| 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. | 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. | Day of commencement of Aranesp |
| Iron Therapy Use | Due to the premature termination of the study no outcome measure data were analyzed. | 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. | 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. | 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. | Over the 15-month observation period |
| Number of Hospitalisations | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period |
| Umhlanga |
| KwaZulu-Natal |
| 4320 |
| South Africa |
| Research Site | Cape Town | Western Cape | 7800 | South Africa |
| Research Site | Durban | 4001 | South Africa |
| Research Site | Kimberley | 8300 | South Africa |
| Research Site | Lenasia | 1821 | South Africa |
| Research Site | Roodepoort | 1709 | South Africa |
| Mean |
| Standard Deviation |
| years |
|
| Gender | Gender data were available for 27 participants | Number | participants |
|
| Race/Ethnicity, Customized | Race data were available for 27 participants | Number | participants |
|
| Baseline Hemoglobin Concentration | Data were available for 11 participants | Mean | Standard Deviation | g/dL |
|
| Baseline Aranesp Route | Number | participants |
|
| Baseline Aranesp Dose | Mean | Standard Deviation | µg/week |
|
| Secondary | 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. | Posted | Over the 15-month observation period |
|
|
| Secondary | Hemoglobin Within the Range 10-12 g/dL Over Time | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | On a continuous basis over the 15-month observation period |
|
|
| Secondary | Erythropoiesis Stimulating Agent (ESA) Usage | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | Over the 15-month observation period |
|
|
| Secondary | 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. | Posted | Day of commencement of Aranesp |
|
|
| Secondary | Iron Therapy Use | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | Over the 15-month observation period |
|
|
| Secondary | 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. | Posted | At each 12-week interval over the observation period |
|
|
| Secondary | C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | Over the 15-month observation period |
|
|
| Secondary | Number of Red Blood Cell Transfusions | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | Over the 15-month observation period |
|
|
| Secondary | Number of Hospitalisations | Due to the premature termination of the study no outcome measure data were analyzed. | Posted | Over the 15-month observation period |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |