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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Patients with CKD |
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| 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 |
| 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 |
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Inclusion Criteria:
Patients ≥18 years of age.
Patients with CKD:
Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.
Exclusion Criteria:
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The study population comprises CKD patients not on dialysis, ESA-naïve at time of initiation of darbepoetin alfa QM, and treated at nephrology clinics in EU and Australia from 01 May 2013. Eligible patients will have received at least three consecutive doses of darbepoetin alfa for correction of anaemia at a QM dosing interval. At each participating study site, all potentially elgible patients are to be considered for enrolment.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Feldkirch | 6807 | Austria | |||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| 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 |
| Linz |
| 4020 |
| Austria |
| Research Site | Vienna | 1220 | Austria |
| Research Site | Dobrich | 9300 | Bulgaria |
| Research Site | Montana | 3400 | Bulgaria |
| Research Site | Pazardzhik | 4400 | Bulgaria |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Plovdiv | 4002 | Bulgaria |
| Research Site | Plovdiv | 4003 | Bulgaria |
| Research Site | Sofia | 1431 | Bulgaria |
| Research Site | Sofia | 1612 | Bulgaria |
| Research Site | Varna | 9000 | Bulgaria |
| Research Site | Vratsa | 3000 | Bulgaria |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Havlíčkův Brod | 580 22 | Czechia |
| Research Site | Nové Město na Moravě | 592 31 | Czechia |
| Research Site | Třebíč | 674 35 | Czechia |
| Research Site | Athens | 10676 | Greece |
| Research Site | Athens | 12462 | Greece |
| Research Site | Pátrai | 26500 | Greece |
| Research Site | Thessaloniki | 54642 | Greece |
| Research Site | Thessaloniki | 56429 | Greece |
| Research Site | Baja | 6500 | Hungary |
| Research Site | Kecskemét | 6000 | Hungary |
| Research Site | Szeged | 6724 | Hungary |
| Research Site | Szigetvár | 7900 | Hungary |
| Research Site | Szombathely | 9700 | Hungary |
| Research Site | Zalaegerszeg | 8900 | Hungary |
| Research Site | Albano Laziale RM | 00041 | Italy |
| Research Site | Lodz | 92-213 | Poland |
| Research Site | Lodz | 93-338 | Poland |
| Research Site | Lublin | 20-718 | Poland |
| Research Site | Poznan | 60-355 | Poland |
| Research Site | Sieradz | 98-200 | Poland |
| Research Site | Stalowa Wola | 37-450 | Poland |
| Research Site | Córdoba | Andalusia | 14004 | Spain |
| Research Site | Badalona | Catalonia | 08916 | Spain |
| Research Site | Barcelona | Catalonia | 08035 | Spain |
| Research Site | Valencia | Valencia | 46010 | Spain |
| Research Site | Valencia | Valencia | 46017 | Spain |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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