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

Completed

• Conditions: Anaemia; Chronic Kidney Disease (CKD)

• Registration Number: NCT02185911
• Lead Sponsor: Amgen

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
TSAT, ferritin and albumin values	Throughout the 46 week observation period	TSAT, ferritin and albumin over the observation period
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
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)
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
Hospitalisations	Throughout the 46 week observation period	Hospitalisations (duration and primary cause) over the observation period
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
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)

Trial Locations

Locations (1)

Research Site; 🇪🇸 Valencia, Comunidad Valenciana, Spain