Anaemia, Chronic Kidney Disease (CKD)
Conditions
Keywords
chronic kidney disease,, anaemia correction/maintenance,, non dialysis,
Brief summary
To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
Detailed description
Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis. There is very little published literature describing QM correction in a real-world setting. Data obtained from this study are intended to contribute to filling a literature gap and to provide a robust source of information for physicians.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients ≥18 years of age. 2. Patients with CKD: 1. Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency. 2. Hb \<10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing. 3. Commenced darbepoetin alfa at QM dosing frequency during or after August 2013. 4. Received at least three consecutive doses of darbepoetin alfa at QM dosing frequency, being the initiation dose and two further doses at QM dosing frequency. 3. Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.
Exclusion criteria
1. Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa. 2. Patient was enrolled in an interventional device or drug study at any time during the 46-week data observation period or within 30 days prior to commencement of the data observtion period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly Haemoglobin values | During the 32 weeks post initiation of darbepoetin alfa QM | Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin values | Throughout the 46 week observation period | Haemoglobin over the observation period |
| Change in Haemoglobin values | Throughout the 46 week observation period | Change in haemoglobin from baseline |
| Increase in haemoglobin from baseline | Throughout the 46 week observation period | Increase in haemoglobin of at least 1g/dL from baseline |
| Haemoglobin excursions | Throughout the 46 week observation period | Haemoglobin excursions (\<10,\>12 g/dL) over the observation period |
| First haemoglobin within 10-12g/dL | During the 32 weeks post initiation of darbepoetin alfa QM | Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL |
| Doses of darbepoetin alfa/other ESAs over time | Throughout the 46 week observation period | Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency) |
| Subjects remaining on darbepoetin alfa QM | During the 32 weeks post initiation of darbepoetin alfa QM | Remaining on darbepoetin alfa QM for the full 32 weeks post initiation |
| TSAT, ferritin and albumin values | Throughout the 46 week observation period | TSAT, ferritin and albumin over the observation period |
| Iron Use | Throughout the 46 week observation period | Iron use (dose/route) over the observation period |
| Transfusions | Throughout the 46 week observation period | Transfusions over the observation period (number of tranfusions and the number of units transfused) |
| Hospitalisations | Throughout the 46 week observation period | Hospitalisations (duration and primary cause) over the observation period |
| first dose frequency change after third dose of darbepoetin alfa QM | During the 32 weeks post initiation of darbepoetin alfa QM | Time from third dose of darbepoetin alfa at QM dosing frequency to first frequency change |
Countries
Austria, Bulgaria, Czechia, Greece, Hungary, Italy, Poland, Spain
Outcome results
None listed