Chronic Kidney Disease, Receiving Dialysis
Conditions
Keywords
Chronic kidney disease, Dialysis, Erythropoiesis stimulating agent, South Africa
Brief 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.
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.
Interventions
DRUGAranesp
Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin Concentration | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Within the Range 10-12 g/dL Over Time | 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 | Over the 15-month observation period | Due to the premature termination of the study no outcome measure data were analyzed. |
| ESA/Aranesp Dose Ratio | 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 | Over the 15-month observation period | Due to the premature termination of the study no outcome measure data were analyzed. |
| Hemoglobin Excursions | 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. |
| C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration | 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 | Over the 15-month observation period | Due to the premature termination of the study no outcome measure data were analyzed. |
| Number of Hospitalisations | 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 | At each 12-week interval over the observation period | Due to the premature termination of the study no outcome measure data were analyzed. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aranesp® Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Aranesp® |
|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 15.1 |
| Baseline Aranesp Dose | 36.6 µg/week STANDARD_DEVIATION 7.5 |
| Baseline Aranesp Route Intravenous | 1 participants |
| Baseline Aranesp Route Subcutaneous | 27 participants |
| Baseline Hemoglobin Concentration | 9.7 g/dL STANDARD_DEVIATION 2 |
| Gender Female | 13 participants |
| Gender Male | 14 participants |
| Race/Ethnicity, Customized Asian | 11 participants |
| Race/Ethnicity, Customized Black | 12 participants |
| Race/Ethnicity, Customized Colored | 3 participants |
| Race/Ethnicity, Customized White/caucasian | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Haemoglobin Concentration
Due to the premature termination of the study no outcome measure data were analyzed.
Time frame: Each 4-week period for the duration of the study period (15 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: Day of commencement of Aranesp
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.
Time frame: 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.
Time frame: On a continuous basis over the 15-month observation period
Secondary
Iron Therapy Use
Due to the premature termination of the study no outcome measure data were analyzed.
Time frame: Over the 15-month observation period
Secondary
Number of Hospitalisations
Due to the premature termination of the study no outcome measure data were analyzed.
Time frame: 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.
Time frame: 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.
Time frame: At each 12-week interval over the observation period