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Study Complete
Sponsor ID
20130301

Observational Study of correction of Anaemia with Darbepoetin alfa at QM dosing interval in patients with CKD not on dialysisADAPTATION

Sponsor ID
20130301
Clinicaltrials.gov ID
NCT02185911
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
N/A
Product
darbepoetin alfa
Type
Observational
Masking
N/A
Enrollment
308
Additional Study Details

Protocol Summary

Primary Outcome Measures

Monthly Haemoglobin values

Timeframe: During the 32 weeks post initiation of darbepoetin alfa QM

Secondary Outcome Measures

Doses of darbepoetin alfa/other ESAs over time

Timeframe: Throughout the 46 week observation period

Haemoglobin values

Timeframe: Throughout the 46 week observation period

Change in Haemoglobin values

Timeframe: Throughout the 46 week observation period

Increase in haemoglobin from baseline

Timeframe: Throughout the 46 week observation period

Haemoglobin excursions

Timeframe: Throughout the 46 week observation period

First haemoglobin within 10-12g/dL

Timeframe: During the 32 weeks post initiation of darbepoetin alfa QM

first dose frequency change after third dose of darbepoetin alfa QM

Timeframe: During the 32 weeks post initiation of darbepoetin alfa QM

Subjects remaining on darbepoetin alfa QM

Timeframe: During the 32 weeks post initiation of darbepoetin alfa QM

TSAT, ferritin and albumin values

Timeframe: Throughout the 46 week observation period

Iron Use

Timeframe: Throughout the 46 week observation period

Transfusions

Timeframe: Throughout the 46 week observation period

Hospitalisations

Timeframe: Throughout the 46 week observation period

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Baja, Hungary, 6500
Status
Recruiting
Location
Research Site
Trebic, Czech Republic, 674 35
Status
Recruiting
Location
Research Site
Zalaegerszeg, Hungary, 8900
Status
Recruiting
Location
Research Site
Nove Mesto na Morave, Czech Republic, 592 31
Status
Recruiting
Location
Research Site
Havlickuv Brod, Czech Republic, 580 22
Status
Recruiting
Location
Research Site
Feldkirch, Austria, 6807
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Anemia
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Jun 2014 - Apr 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    (1) Patients ≥18 years of age. (2) Patients with CKD: (a) Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency. (b) Hb <10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing. (c) Commenced darbepoetin alfa at QM dosing frequency during or after August 2013. (d) 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.