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

Anaemia Clinical Trial

— ADAPTATION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185911
• Other study ID #: 20130301
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: March 4, 2016
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Regulatory AgencySpain: Regional Autorities of selected sitesAustria: Bundesamt für Sicherheit im GesundheitswesenGreece: Each site's Ethics CommitteePoland: Central Ethics CommitteeBulgaria: Bulgarian Drug AgencyBulgaria: Ethics Committee for Multicentre Trials (ECMT)Czech Republic: Ethics Committees (local and multicentre)Czech Republic: State Institute for Drug Control (SUKL)Czech Republic: AFP (Association of innovative pharmaceutical industries)Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines, National Institute of Pharmacy Directorate Clinical Trials Department
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Austria	Research Site	Feldkirch
Austria	Research Site	Linz
Austria	Research Site	Wien
Bulgaria	Research Site	Dobrich
Bulgaria	Research Site	Montana
Bulgaria	Research Site	Pazardjik
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Vratza
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Havlickuv Brod
Czech Republic	Research Site	Nove Mesto na Morave
Czech Republic	Research Site	Trebic
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hungary	Research Site	Baja
Hungary	Research Site	Kecskemet
Hungary	Research Site	Szeged
Hungary	Research Site	Szigetvar
Hungary	Research Site	Szombathely
Hungary	Research Site	Zalaegerszeg
Italy	Research Site	Albano Laziale RM
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Sieradz
Poland	Research Site	Stalowa Wola
Spain	Research Site	Badalona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Cordoba	Andalucía
Spain	Research Site	Valencia	Comunidad Valenciana
Spain	Research Site	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Bulgaria,  Czech Republic,  Greece,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Haemoglobin values	Haemoglobin over the observation period	Throughout the 46 week observation period	No
Secondary	Change in Haemoglobin values	Change in haemoglobin from baseline	Throughout the 46 week observation period	No
Secondary	Increase in haemoglobin from baseline	Increase in haemoglobin of at least 1g/dL from baseline	Throughout the 46 week observation period	No
Secondary	Haemoglobin excursions	Haemoglobin excursions (<10,>12 g/dL) over the observation period	Throughout the 46 week observation period	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	TSAT, ferritin and albumin values	TSAT, ferritin and albumin over the observation period	Throughout the 46 week observation period	No
Secondary	Iron Use	Iron use (dose/route) over the observation period	Throughout the 46 week observation period	No
Secondary	Transfusions	Transfusions over the observation period (number of tranfusions and the number of units transfused)	Throughout the 46 week observation period	No
Secondary	Hospitalisations	Hospitalisations (duration and primary cause) over the observation period	Throughout the 46 week observation period	No

External Links

•   AmgenTrials clinical trials website