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

March 4, 2016 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Wien, Austria, 1220
        • Research Site
  • Bulgaria
      • Dobrich, Bulgaria, 9300
        • Research Site
      • Montana, Bulgaria, 3400
        • Research Site
      • Pazardjik, Bulgaria, 4400
        • Research Site
      • Plovdiv, Bulgaria, 4003
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1612
        • Research Site
      • Varna, Bulgaria, 9000
        • Research Site
      • Vratza, Bulgaria, 3000
        • Research Site
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Research Site
      • Havlickuv Brod, Czech Republic, 580 22
        • Research Site
      • Nove Mesto na Morave, Czech Republic, 592 31
        • Research Site
      • Trebic, Czech Republic, 674 35
        • Research Site
  • Greece
      • Athens, Greece, 12462
        • Research Site
      • Athens, Greece, 10676
        • Research Site
      • Patra, Greece, 26500
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
      • Thessaloniki, Greece, 54642
        • Research Site
  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Kecskemet, Hungary, 6000
        • Research Site
      • Szeged, Hungary, 6724
        • Research Site
      • Szigetvar, Hungary, 7900
        • Research Site
      • Szombathely, Hungary, 9700
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Italy
      • Albano Laziale RM, Italy, 00041
        • Research Site
  • Poland
      • Lodz, Poland, 93-338
        • Research Site
      • Lodz, Poland, 92-213
        • Research Site
      • Lublin, Poland, 20-718
        • Research Site
      • Poznan, Poland, 60-355
        • Research Site
      • Sieradz, Poland, 98-200
        • Research Site
      • Stalowa Wola, Poland, 37-450
        • Research Site
  • Spain
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
    • Cataluña
      • Badalona, Cataluña, Spain, 08916
        • Research Site
      • Barcelona, Cataluña, Spain, 08035
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Research Site
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population comprises CKD patients not on dialysis, ESA-naïve at time of initiation of darbepoetin alfa QM, and treated at nephrology clinics in EU and Australia from 01 May 2013. Eligible patients will have received at least three consecutive doses of darbepoetin alfa for correction of anaemia at a QM dosing interval. At each participating study site, all potentially elgible patients are to be considered for enrolment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Cohort 1
Patients with CKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly Haemoglobin values
Time Frame: 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
During the 32 weeks post initiation of darbepoetin alfa QM

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doses of darbepoetin alfa/other ESAs over time
Time Frame: Throughout the 46 week observation period
Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency)
Throughout the 46 week observation period
Haemoglobin values
Time Frame: Throughout the 46 week observation period
Haemoglobin over the observation period
Throughout the 46 week observation period
Change in Haemoglobin values
Time Frame: Throughout the 46 week observation period
Change in haemoglobin from baseline
Throughout the 46 week observation period
Increase in haemoglobin from baseline
Time Frame: Throughout the 46 week observation period
Increase in haemoglobin of at least 1g/dL from baseline
Throughout the 46 week observation period
Haemoglobin excursions
Time Frame: Throughout the 46 week observation period
Haemoglobin excursions (<10,>12 g/dL) over the observation period
Throughout the 46 week observation period
First haemoglobin within 10-12g/dL
Time Frame: During the 32 weeks post initiation of darbepoetin alfa QM
Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL
During the 32 weeks post initiation of darbepoetin alfa QM
first dose frequency change after third dose of darbepoetin alfa QM
Time Frame: 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
During the 32 weeks post initiation of darbepoetin alfa QM
Subjects remaining on darbepoetin alfa QM
Time Frame: During the 32 weeks post initiation of 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
TSAT, ferritin and albumin values
Time Frame: Throughout the 46 week observation period
TSAT, ferritin and albumin over the observation period
Throughout the 46 week observation period
Iron Use
Time Frame: Throughout the 46 week observation period
Iron use (dose/route) over the observation period
Throughout the 46 week observation period
Transfusions
Time Frame: Throughout the 46 week observation period
Transfusions over the observation period (number of tranfusions and the number of units transfused)
Throughout the 46 week observation period
Hospitalisations
Time Frame: Throughout the 46 week observation period
Hospitalisations (duration and primary cause) over the observation period
Throughout the 46 week observation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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