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

Amgen

Status: Completed

Conditions: Chronic Kidney Disease (CKD); Anaemia

Study type: Observational

Funder types: Industry

Identifiers

NCT02185911

20130301

Details and patient eligibility

About

To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM

Full 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.

Enrollment: 308 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

308 participants in 1 patient group

Cohort 1

Description:

Patients with CKD