AnemiaPhase 3NCT00642304
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [C.E.R.A.] in people with Anemia, run by Hoffmann-La Roche at 23 sites in Netherlands.
Trial summary
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 23 sitesNetherlands
- Study dates
- 27 Mar 2008to 9 Dec 2009
- Phase
- Phase 3
- 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
Who may be able to join
- Chronic renal anemia
- Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
Who cannot join
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
- Acute or chronic bleeding requiring therapy within previous 8 weeks
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Netherlands23 sites
Twenteborg Ziekenhuis
Almelo, 7609 PP
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
Amersfoort, 3818 ES
Bovenij Zkhs; Cardiologie Afd.
Amsterdam, 1034 CS
Wilhelmina Ziekenhuis; Inwendige Geneeskunde
Assen, 9401 RK
Rode Kruis Ziekenhuis; Inwendige Geneeskunde
Beverwijk, 1942LE
Amphia Ziekenhuis
Breda, 4819 EV
Reinier De Graaf Groep
Delft, 2625 AD
Slingeland Ziekenhuis; Inwendige Geneeskunde
Doetinchem, 7009 BL
Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
Dordrecht, 3318 AT
Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
Drachten, 9202 NN
Oosterscheldeziekenhuis
Goes, 4462 RA
Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
Gouda, 2803 HH
Atrium Medisch Centrum; Nephrology
Heerlen, 6419 PC
Bethesda Hospital; Internal Medicine
Hoogeveen, 7909
Leiden University Medical Center; Nierziekten
Leiden, 2333 ZA
Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
Leiderdorp, 2353 GA
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, 6229 HX
Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
Nijmegen, 6525 GA
Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
Rotterdam, 3015 GD
Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
Rotterdam, 3078 HT
Ikazia Ziekenhuis; Interne Oncologie
Rotterdam, 3083 AN
Zorgsaam Ziekenhuis
Terneuzen, 4535 PA
Diakonessenhuis
Utrecht, 3582 KE
About this study
Official title: A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methoxy polyethylene glycol-epoetin beta [C.E.R.A.]Drug
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
| Study group | Role | What they receive |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Measured: EEP (Weeks 16 to 24)
Secondary outcomes (5)
Mean Change in Hb Concentration Between SVP and the EEP
The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Measured: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
The EEP was defined as Week 16 to Week 24.
Measured: EEP (Weeks 16 to 24)
Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
The EEP was defined as Week 16 to Week 24.
Measured: EEP (Weeks 16 to 24)
Percentage of Participants With Blood Transfusion
Measured: Baseline up to Week 28
Percentage of Participants With Dose Adjustment
A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.
Measured: Baseline up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study start27 Mar 2008
- Primary completion9 Dec 2009
- Study completion9 Dec 2009
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT00642304
- Sponsor's protocol ID
- ML20937
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2008
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis
- ClinicalTrials.gov ID
- NCT00642304
- Acronym / sponsor ID
- ML20937
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2008 (actual)
- Primary completion
- 9 Dec 2009 (actual)
- Study completion
- 9 Dec 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 7 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic renal anemia
- Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
Key exclusion criteria (3 listed)
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
- Acute or chronic bleeding requiring therapy within previous 8 weeks
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 |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta [C.E.R.A.]Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values. | Drug | methoxy polyethylene glycol-epoetin beta |
Primary outcome
Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
Time frame: EEP (Weeks 16 to 24)
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
5 secondary outcomes
Mean Change in Hb Concentration Between SVP and the EEP
Time frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
Time frame: EEP (Weeks 16 to 24)
Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
Time frame: EEP (Weeks 16 to 24)
Percentage of Participants With Blood Transfusion
Time frame: Baseline up to Week 28
Percentage of Participants With Dose Adjustment
Time frame: Baseline up to Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- 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
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [C.E.R.A.] in people with Anemia, run by Hoffmann-La Roche at 23 sites in Netherlands.
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 2 inclusion and 3 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2016). 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 Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) (time frame: EEP (Weeks 16 to 24)). 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 26 Jun 2018.