Erythropoiesis Stimulating Agent PharmacodynamicsNCT01666301
ESAs, Reticulocyte Dynamic and Hemoglobin Variability
A study testing comparison between darbepoetin alfa and C.E.R.A. and different administration intervals in people with Erythropoiesis Stimulating Agent Pharmacodynamics, run by Ospedale Regionale di Locarno at 1 site in Switzerland.
Trial summary
Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythropoiesis Stimulating Agent Pharmacodynamics
- What is being tested?
- comparison between darbepoetin alfa and C.E.R.A. and different administration intervals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Apr 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic patients aged 18 years or older, undergoing dialysis 3 times a week for at least 8 weeks before screening, necessitating continuous subcutaneous treatment with weekly Darbepoetin alfa or Erythropoietin beta to maintain hemoglobin (Hb) targets
Who cannot join
- pregnancy; not respecting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.
Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.
- Being tested
- comparison between darbepoetin alfa and C.E.R.A. and different administration intervals
- Keywords
- Erythropoietin stimulating agents, Hemoglobin, Reticulocytes, Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison between darbepoetin alfa and C.E.R.A. and different administration intervalsDrug
| Study group | Role | What they receive |
|---|---|---|
| C.E.R.A. | Active comparator | C.E.R.A. every 4 and then every 2 weeks Receives: Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals |
| Darbepoetin | Active comparator | Darbepoetin alfa every 4 and then every 2 weeks Receives: Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervals |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin variability
Measured: 2 years
Secondary outcomes (4)
differences in reticulocyte count over time
Measured: 2 years
risk of hemoglobin overshooting (HR)
Measured: 2 years
superiority of every 2 week administration
Measured: 2 years
reticulocyte variability
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startFeb 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erythropoiesis Stimulating Agent PharmacodynamicsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Locarno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Gabutti, MD, Ospedale Regionale di Locarno
- Investigators
- Luca Gabutti, MD, Principal investigator, Ospedale Regionale Locarno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666301
- Sponsor's protocol ID
- Epo-Loc1
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
Publications
Forni V, Bianchi G, Ogna A, Salvade I, Vuistiner P, Burnier M, Gabutti L. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with Darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrol. 2013 Jul 22;14:157. doi: 10.1186/1471-2369-14-157.
PubMed 23870287
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01666301
- Acronym / sponsor ID
- Epo-Loc1
- Keywords
- Erythropoietin stimulating agents, Hemoglobin, Reticulocytes, Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ospedale Regionale di LocarnoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Aug 2012 (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.
Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.
Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C.E.R.A. | Active comparator | Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervalsC.E.R.A. every 4 and then every 2 weeks |
| Darbepoetin | Active comparator | Drug: comparison between darbepoetin alfa and C.E.R.A. and different administration intervalsDarbepoetin alfa every 4 and then every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic patients aged 18 years or older, undergoing dialysis 3 times a week for at least 8 weeks before screening, necessitating continuous subcutaneous treatment with weekly Darbepoetin alfa or Erythropoietin beta to maintain hemoglobin (Hb) targets
Key exclusion criteria (1 listed)
- pregnancy; not respecting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison between darbepoetin alfa and C.E.R.A. and different administration intervals | Drug | C.E.R.A., Darbepoetin |
Primary outcome
hemoglobin variability
Time frame: 2 years
4 secondary outcomes
differences in reticulocyte count over time
Time frame: 2 years
risk of hemoglobin overshooting (HR)
Time frame: 2 years
superiority of every 2 week administration
Time frame: 2 years
reticulocyte variability
Time frame: 2 years
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 17 Aug 2012.
- Derived from this study: PubMed 23870287Forni V, Bianchi G, Ogna A, Salvade I, Vuistiner P, Burnier M, Gabutti L. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with Darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrol. 2013 Jul 22;14:157. doi: 10.1186/1471-2369-14-157.
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.
Luca Gabutti, MD principal investigator
Ospedale Regionale Locarno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison between darbepoetin alfa and C.E.R.A. and different administration intervals in people with Erythropoiesis Stimulating Agent Pharmacodynamics, run by Ospedale Regionale di Locarno at 1 site in Switzerland.
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 1 inclusion and 1 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 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
hemoglobin variability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01666301, which also lists 1 linked publication.
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 17 Aug 2012.