AnemiaNCT01105494
An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia
An observational study of Anemia, run by Hoffmann-La Roche at 1 site in Morocco.
Trial summary
This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta [Neorecormon] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin beta [NeoRecormon]
- How many people
- 6,000 participants
- Where
- 1 siteMorocco
- Study dates
- Dec 2008to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dialysis patients with end-stage kidney disease on treatment with epoetin beta [Neorecormon]
Who may be able to join
- Adult patients >/=18 years of age
- Dialysis patients with chronic renal anemia
- Written informed consent
Who cannot join
- Red blood cell transfusion in the previous 2 months
- Severe neuropsychological disorder
- Diabetic patients with serious complications
- This trial is being conducted in Morocco.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease
This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta [Neorecormon] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.
- Conditions
- Anemia
- Being tested
- epoetin beta [NeoRecormon]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin beta [NeoRecormon]Drug
As prescribed by physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment: Kidney Disease Quality of Life Questionnaire
Measured: Throughout study: 6 months
Secondary outcomes (1)
Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life
Measured: Throughout study: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 6,000 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
- NCT01105494
- Sponsor's protocol ID
- ML21906
- Status last verified
- Jun 2011
- First submitted
- 14 Apr 2010
- Last updated
- 13 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT01105494
- Acronym / sponsor ID
- ML21906
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Apr 2010 (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.
This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta [Neorecormon] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dialysis patients with end-stage kidney disease on treatment with epoetin beta [Neorecormon]
Key inclusion criteria (3 listed)
- Adult patients >/=18 years of age
- Dialysis patients with chronic renal anemia
- Written informed consent
Key exclusion criteria (4 listed)
- Red blood cell transfusion in the previous 2 months
- Severe neuropsychological disorder
- Diabetic patients with serious complications
- This trial is being conducted in Morocco.
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 |
|---|---|---|
| epoetin beta [NeoRecormon]As prescribed by physician | Drug | – |
Primary outcome
Quality of life assessment: Kidney Disease Quality of Life Questionnaire
Time frame: Throughout study: 6 months
1 secondary outcome
Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life
Time frame: Throughout study: 6 months
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 13 Sep 2012.
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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
1 site 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 1 site in Morocco.
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 4 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 13 Sep 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 Morocco. 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?
Quality of life assessment: Kidney Disease Quality of Life Questionnaire (time frame: Throughout study: 6 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 13 Sep 2012.