AnaemiaADAPTATIONNCT02185911
Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis
An observational study of Anaemia and Chronic Kidney Disease (CKD), run by Amgen at 40 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anaemia, Chronic Kidney Disease (CKD)
- How many people
- 308 participants
- Where
- 40 sitesin 8 countries
- Study dates
- Jun 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 8 countries.
40 sites in 8 countries
Bulgaria10 sites
Research Site
Dobrich, 9300
Research Site
Montana, 3400
Research Site
Pazardzhik, 4400
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4002
Research Site
Plovdiv, 4003
Research Site
Sofia, 1431
Research Site
Sofia, 1612
Research Site
Varna, 9000
Research Site
Vratsa, 3000
Hungary6 sites
Research Site
Baja, 6500
Research Site
Kecskemét, 6000
Research Site
Szeged, 6724
Research Site
Szigetvár, 7900
Research Site
Szombathely, 9700
Research Site
Zalaegerszeg, 8900
Poland6 sites
Research Site
Lodz, 92-213
Research Site
Lodz, 93-338
Research Site
Lublin, 20-718
Research Site
Poznan, 60-355
Research Site
Sieradz, 98-200
Research Site
Stalowa Wola, 37-450
Greece5 sites
Research Site
Athens, 10676
Research Site
Athens, 12462
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 54642
Research Site
Thessaloniki, 56429
Spain5 sites
Research Site
Badalona, Catalonia, 08916
Research Site
Barcelona, Catalonia, 08035
Research Site
Córdoba, Andalusia, 14004
Research Site
Valencia, Valencia, 46010
Research Site
Valencia, Valencia, 46017
Czechia4 sites
Research Site
Brno, 625 00
Research Site
Havlíčkův Brod, 580 22
Research Site
Nové Město na Moravě, 592 31
Research Site
Třebíč, 674 35
Austria3 sites
Research Site
Feldkirch, 6807
Research Site
Linz, 4020
Research Site
Vienna, 1220
About this study
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
To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
Read the 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.
- Conditions
- Anaemia, Chronic Kidney Disease (CKD)
- Keywords
- chronic kidney disease,, anaemia correction/maintenance,, non dialysis,
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Haemoglobin values
Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM
Measured: During the 32 weeks post initiation of darbepoetin alfa QM
Secondary outcomes (12)
Doses of darbepoetin alfa/other ESAs over time
Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency)
Measured: Throughout the 46 week observation period
Haemoglobin values
Haemoglobin over the observation period
Measured: Throughout the 46 week observation period
Change in Haemoglobin values
Change in haemoglobin from baseline
Measured: Throughout the 46 week observation period
Increase in haemoglobin from baseline
Increase in haemoglobin of at least 1g/dL from baseline
Measured: Throughout the 46 week observation period
Haemoglobin excursions
Haemoglobin excursions (<10,>12 g/dL) over the observation period
Measured: Throughout the 46 week observation period
First haemoglobin within 10-12g/dL
Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL
Measured: During the 32 weeks post initiation of darbepoetin alfa QM
first dose frequency change after third dose of darbepoetin alfa QM
Time from third dose of darbepoetin alfa at QM dosing frequency to first frequency change
Measured: During the 32 weeks post initiation of darbepoetin alfa QM
Subjects remaining on darbepoetin alfa QM
Remaining on darbepoetin alfa QM for the full 32 weeks post initiation
Measured: During the 32 weeks post initiation of darbepoetin alfa QM
TSAT, ferritin and albumin values
TSAT, ferritin and albumin over the observation period
Measured: Throughout the 46 week observation period
Iron Use
Iron use (dose/route) over the observation period
Measured: Throughout the 46 week observation period
Transfusions
Transfusions over the observation period (number of tranfusions and the number of units transfused)
Measured: Throughout the 46 week observation period
Hospitalisations
Hospitalisations (duration and primary cause) over the observation period
Measured: Throughout the 46 week observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185911
- Sponsor's protocol ID
- 20130301
- Acronym
- ADAPTATION
- Status last verified
- Mar 2016
- First submitted
- 26 Jun 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02185911
- Acronym / sponsor ID
- ADAPTATION / 20130301
- Conditions
- Anaemia, Chronic Kidney Disease (CKD)
- Keywords
- chronic kidney disease,, anaemia correction/maintenance,, non dialysis,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with CKD |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Patients ≥18 years of age.
- Patients with CKD:
- Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
Doses of darbepoetin alfa/other ESAs over time
Time frame: Throughout the 46 week observation period
Haemoglobin values
Time frame: Throughout the 46 week observation period
Change in Haemoglobin values
Time frame: Throughout the 46 week observation period
Increase in haemoglobin from baseline
Time frame: Throughout the 46 week observation period
Haemoglobin excursions
Time frame: Throughout the 46 week observation period
First haemoglobin within 10-12g/dL
Time frame: 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
Subjects remaining on darbepoetin alfa QM
Time frame: During the 32 weeks post initiation of darbepoetin alfa QM
TSAT, ferritin and albumin values
Time frame: Throughout the 46 week observation period
Iron Use
Time frame: Throughout the 46 week observation period
Transfusions
Time frame: Throughout the 46 week observation period
Hospitalisations
Time frame: Throughout the 46 week observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
40 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaemia and Chronic Kidney Disease (CKD), run by Amgen at 40 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Bulgaria, Hungary, Poland, Greece, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Haemoglobin values (time frame: During the 32 weeks post initiation of darbepoetin alfa QM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.