Clinical trial NCT02185911: Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaemia
Chronic Kidney Disease (CKD)
Keywords: chronic kidney disease,
anaemia correction/maintenance,
non dialysis,
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monthly Haemoglobin values
timeFrame: During the 32 weeks post initiation of darbepoetin alfa QM
Secondary outcomes:
measure: Doses of darbepoetin alfa/other ESAs over time
timeFrame: Throughout the 46 week observation period
measure: Haemoglobin values
timeFrame: Throughout the 46 week observation period
measure: Change in Haemoglobin values
timeFrame: Throughout the 46 week observation period
measure: Increase in haemoglobin from baseline
timeFrame: Throughout the 46 week observation period
measure: Haemoglobin excursions
timeFrame: Throughout the 46 week observation period
measure: First haemoglobin within 10-12g/dL
timeFrame: During the 32 weeks post initiation of darbepoetin alfa QM
measure: first dose frequency change after third dose of darbepoetin alfa QM
timeFrame: During the 32 weeks post initiation of darbepoetin alfa QM
measure: Subjects remaining on darbepoetin alfa QM
timeFrame: During the 32 weeks post initiation of darbepoetin alfa QM
measure: TSAT, ferritin and albumin values
timeFrame: Throughout the 46 week observation period
measure: Iron Use
timeFrame: Throughout the 46 week observation period
measure: Transfusions
timeFrame: Throughout the 46 week observation period
measure: Hospitalisations
timeFrame: Throughout the 46 week observation period
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Dobrich
country: Bulgaria
facility: Research Site
city: Montana
country: Bulgaria
facility: Research Site
city: Pazardjik
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Vratza
country: Bulgaria
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Havlickuv Brod
country: Czech Republic
facility: Research Site
city: Nove Mesto na Morave
country: Czech Republic
facility: Research Site
city: Trebic
country: Czech Republic
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Baja
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szigetvar
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Albano Laziale RM
country: Italy
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sieradz
country: Poland
facility: Research Site
city: Stalowa Wola
country: Poland
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucía
city: Badalona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: