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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT02185911

Collaborator

(none)

308

Enrollment

Locations

Duration (Months)

7.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anaemia Chronic Kidney Disease (CKD)

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 Design

Study Type:

Observational

Actual Enrollment :

308 participants

Observational Model:

Cohort

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 Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Patients with CKD

Outcome Measures

Primary Outcome Measures

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

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)
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
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
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
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
TSAT, ferritin and albumin values [Throughout the 46 week observation period]
TSAT, ferritin and albumin over the observation period
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)
Hospitalisations [Throughout the 46 week observation period]
Hospitalisations (duration and primary cause) over the observation period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients ≥18 years of age.
Patients with CKD:
Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency.
Hb <10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing.
Commenced darbepoetin alfa at QM dosing frequency during or after August 2013.
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.
Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.

Exclusion Criteria:

Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Feldkirch		Austria	6807
2	Research Site	Linz		Austria	4020
3	Research Site	Wien		Austria	1220
4	Research Site	Dobrich		Bulgaria	9300
5	Research Site	Montana		Bulgaria	3400
6	Research Site	Pazardjik		Bulgaria	4400
7	Research Site	Plovdiv		Bulgaria	4000
8	Research Site	Plovdiv		Bulgaria	4002
9	Research Site	Plovdiv		Bulgaria	4003
10	Research Site	Sofia		Bulgaria	1431
11	Research Site	Sofia		Bulgaria	1612
12	Research Site	Varna		Bulgaria	9000
13	Research Site	Vratza		Bulgaria	3000
14	Research Site	Brno		Czech Republic	625 00
15	Research Site	Havlickuv Brod		Czech Republic	580 22
16	Research Site	Nove Mesto na Morave		Czech Republic	592 31
17	Research Site	Trebic		Czech Republic	674 35
18	Research Site	Athens		Greece	10676
19	Research Site	Athens		Greece	12462
20	Research Site	Patra		Greece	26500
21	Research Site	Thessaloniki		Greece	54642
22	Research Site	Thessaloniki		Greece	56429
23	Research Site	Baja		Hungary	6500
24	Research Site	Kecskemet		Hungary	6000
25	Research Site	Szeged		Hungary	6724
26	Research Site	Szigetvar		Hungary	7900
27	Research Site	Szombathely		Hungary	9700
28	Research Site	Zalaegerszeg		Hungary	8900
29	Research Site	Albano Laziale RM		Italy	00041
30	Research Site	Lodz		Poland	92-213
31	Research Site	Lodz		Poland	93-338
32	Research Site	Lublin		Poland	20-718
33	Research Site	Poznan		Poland	60-355
34	Research Site	Sieradz		Poland	98-200
35	Research Site	Stalowa Wola		Poland	37-450
36	Research Site	Cordoba	Andalucía	Spain	14004
37	Research Site	Badalona	Cataluña	Spain	08916
38	Research Site	Barcelona	Cataluña	Spain	08035
39	Research Site	Valencia	Comunidad Valenciana	Spain	46010
40	Research Site	Valencia	Comunidad Valenciana	Spain	46017