AnemiaNCT01356589
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
An observational study of Anemia, run by Hoffmann-La Roche at 33 sites in Greece.
Trial summary
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 1,288 participants
- Where
- 33 sitesGreece
- Study dates
- 30 Sep 2010to 31 Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Chronic kidney disease patients with anemia treated with Mircera
Who may be able to join
- Adult patients, >/= 18 years of age
- Chronic kidney disease in predialysis (stage 3 and 4) and dialysis
- Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent
Who cannot join
- Participation in an interventional clinical trial within the retrospective observation period
- Contraindications to Mircera administration as per label or judged by the investigator
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Greece33 sites
Timios Stavros Clinic; Nephrology Department
Aigáleo, 12244
General Hospital of Artas; Nephrology
Arta, 47100
Attikon Center; Nephrology
Athens, 11362
Athinaiki Private Clinic
Athens, 11521
Hospital henry dunant; Nephrology
Athens, 11526
General Hospital Hippokration of Athens; Nephrology
Athens, 11527
General Hospital Of Athens G.Gennimatas; Nephrology
Athens, 11527
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, 11528
General Hospital Of West Attikis; Nephrology
Athens, 12351
University Hospital Attikon ; Pathology Clinic
Athens, 124 61
General Hospital Agia Olga; Nephrology
Athens, 14233
Iaso General Private Clinic; Nephrology
Athens, 15562
Iatriko Athinon Clinic Dafnis; Nephrology Department
Daphni-athens, 17237
General Hospital Of Dramas; Dialysis Center Unit
Drama, 66100
University Hospital Of Heraklion; Nefrologiki Clinic
Heraklion, 71110
General Hospital Of Katerinis; Nephrology Unit
Katerini
General Hospital Of Lamias; Nephrology
Lamia, 35100
Univeristy Hospital of Larissa; Nephrology
Larissa, 41 110
Eytychios Patsidis Center Of Haemodialysis
Larissa, 41335
General Hospital Of Leykadas; Dialysis Center Unit
Leykada, 31100
Leivadia General Hospital; Nephrologic Clinic
Livadeia, 32100
Kyanous Stavros of Patras, Renal Disease Therapy Unit
Pátrai, 26225
Olympion Therapeytirion; Nefrology
Pátrai, 26443
General Hospital Tzanio ; Nephrology
Piraeus, 18536
General Hospital Of Chalkidikis; Dialysis Center Unit
Polygyros, 63100
Rodos General Hospital; Nephrologic Clinic
Rhodes, 85100
Alpha Nephrodynamiki Of Serres; Dialysis Center Unit
Serres
Ahepa Hospital; 1St Dept. of Medicine
Thessaloniki, 54636
IPPOKRATES Private Dialysis Centre
Thessaloniki, 54643
General Hospital Of Thessalonikis Papageorgiou; Nephrology
Thessaloniki, 56403
Alfa Nefrodynamiki; Nefrology
Thessaloniki, 57500
Thessaliki Nossileytiki; Nephrology
Volos, 38221
General Hospital of Volos; Nephrology
Volos, 38222
About this study
Official title: Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.
- Conditions
- Anemia
- Medical subject headings
- Anemia
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Hemoglobin Cycling
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.
Measured: 9 months
Secondary outcomes (2)
Number of Full Hemoglobin Cycles Per Participant
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.
Measured: 9 months
Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study start30 Sep 2010
- Primary completion31 Jul 2012
- Study completion31 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Time perspective
- Retrospective
- Enrolment
- 1,288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356589
- Sponsor's protocol ID
- ML25289
- Status last verified
- May 2017
- First submitted
- 18 May 2011
- Last updated
- 5 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)
- ClinicalTrials.gov ID
- NCT01356589
- Acronym / sponsor ID
- ML25289
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,288 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 31 Jul 2012 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Posted 28 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic kidney disease patients with anemia treated with Mircera
Key inclusion criteria (3 listed)
- Adult patients, >/= 18 years of age
- Chronic kidney disease in predialysis (stage 3 and 4) and dialysis
- Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent
Key exclusion criteria (2 listed)
- Participation in an interventional clinical trial within the retrospective observation period
- Contraindications to Mircera administration as per label or judged by the investigator
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
Percentage of Participants With at Least One Hemoglobin Cycling
Time frame: 9 months
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.
2 secondary outcomes
Number of Full Hemoglobin Cycles Per Participant
Time frame: 9 months
Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Hoffmann-La Roche at 33 sites in Greece.
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 3 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Greece. 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?
Yes. Results are posted in the registry (first posted 28 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With at Least One Hemoglobin Cycling (time frame: 9 months). 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 5 Jul 2017.