Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study of Correction of Anaemia With Darbepoetin Alfa at Monthly Dose Frequency in EU and Australian Patients With Chronic Kidney Disease Not on Dialysis

Conditions
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Anaemia, Chronic Kidney Disease (CKD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age. Patients with CKD: Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency. Hb <10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing. Commenced darbepoetin alfa at QM dosing frequency during or after August 2013. 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. Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements. Exclusion Criteria: Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with CKD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly Haemoglobin values | Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM | During the 32 weeks post initiation of darbepoetin alfa QM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doses of darbepoetin alfa/other ESAs over time | Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency) | Throughout the 46 week observation period | 
| Haemoglobin values | Haemoglobin over the observation period | Throughout the 46 week observation period | 
| Change in Haemoglobin values | Change in haemoglobin from baseline | Throughout the 46 week observation period | 
| Increase in haemoglobin from baseline | Increase in haemoglobin of at least 1g/dL from baseline | Throughout the 46 week observation period | 
| Haemoglobin excursions | Haemoglobin excursions (<10,>12 g/dL) over the observation period | Throughout the 46 week observation period | 
| First haemoglobin within 10-12g/dL | Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL | During the 32 weeks post initiation of darbepoetin alfa QM | 
| first dose frequency change after third dose of darbepoetin alfa QM | Time from third dose of darbepoetin alfa at QM dosing frequency to first frequency change | During the 32 weeks post initiation of darbepoetin alfa QM | 
| Subjects remaining on darbepoetin alfa QM | Remaining on darbepoetin alfa QM for the full 32 weeks post initiation | During the 32 weeks post initiation of darbepoetin alfa QM | 
| TSAT, ferritin and albumin values | TSAT, ferritin and albumin over the observation period | Throughout the 46 week observation period | 
| Iron Use | Iron use (dose/route) over the observation period | Throughout the 46 week observation period | 
| Transfusions | Transfusions over the observation period (number of tranfusions and the number of units transfused) | Throughout the 46 week observation period | 
| Hospitalisations | Hospitalisations (duration and primary cause) over the observation period | Throughout the 46 week observation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease,, anaemia correction/maintenance,, non dialysis,