AnemiaPhase 3NCT00605293

A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta and Epoetin alfa in people with Anemia, run by Hoffmann-La Roche at 19 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: methoxy polyethylene glycol-epoetin beta and Epoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 19 sitesSpain
Study dates: Jan 2008to Jan 2010
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;
continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
regular hemodialysis for greater than or equal to (>=) 3 months

Who cannot join

transfusion of red blood cells during previous 2 months
poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Spain19 sites

Study site
Badajoz, Badajoz, 06300
Study site
Barcelona, Barcelona, 08035
Study site
Cáceres, Caceres, 10310
Study site
Cádizv, Cadiz, 11008
Study site
Castellon, Castellon, 12004
Study site
Ciudad Real, Ciudad Real, 13005
Study site
Huelva, Huelva, 21005
Study site
Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28905
Study site
Marbella, Malaga, 29603
Study site
Pontevedra, Pontevedra, 36071
Study site
Salamanca, Salamanca, 37008
Study site
Teruel, Teruel, 44003
Study site
Tudela, Navarre, 46010
Study site
Valencia, Valencia, 46009
Study site
Valencia, Valencia, 46010
Study site
Zamora, Zamora, 49022
Study site
Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Conditions: Anemia
Being tested: methoxy polyethylene glycol-epoetin beta, Epoetin alfa
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 betaDrug
Also called Mircera; C.E.R.A
120, 200 or 360 micrograms iv/month (starting dose)
Epoetin alfaDrug
As prescribed

Study groups in NCT00605293
Study group	Role	What they receive
C.E.R.A	Experimental	Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. Receives: Drug: methoxy polyethylene glycol-epoetin beta
Epoetin Alfa	Active comparator	Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks. Receives: Drug: Epoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.
Measured: EEP (Week 16 to 23)

Secondary outcomes (5)

Change in Hb Concentrations Between Baseline SVP and the EEP
Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).
Measured: SVP (Week -4 to -1), EEP (Week 16 to 23)
Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP
Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.
Measured: EEP (Week 16 to 23)
Mean Time Spent in Hb Range 10-12 g/dL
Measured: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
Measured: DTP (Week 0 to 15) and EEP (Week 16 to 23)
Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP
RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).
Measured: DTP (Week 0 to 15) up to EEP (Week 16 to 23)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jan 2010

First posted31 Jan 2008 (estimated)
Study startJan 2008
Primary completionJan 2010
Study completionJan 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00605293
Sponsor's protocol ID: ML21060
Other IDs: 2007-002065-12
Status last verified: Oct 2013
First submitted: 18 Jan 2008
Last updated: 13 May 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
PubMed 26965694

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia
ClinicalTrials.gov ID: NCT00605293
Acronym / sponsor ID: ML21060
Conditions: Anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 31 Jan 2008 (estimated)
Results: Posted 13 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
C.E.R.A	Experimental	Drug: methoxy polyethylene glycol-epoetin betaParticipants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
Epoetin Alfa	Active comparator	Drug: Epoetin alfaParticipants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

chronic renal anemia;
continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
regular hemodialysis for greater than or equal to (>=) 3 months

Key exclusion criteria (2 listed)

transfusion of red blood cells during previous 2 months
poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

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 betaAlso: Mircera; C.E.R.A120, 200 or 360 micrograms iv/month (starting dose)	Drug	C.E.R.A
Epoetin alfaAs prescribed	Drug	Epoetin Alfa

Primary outcome

Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
Time frame: EEP (Week 16 to 23)
Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.

5 secondary outcomes

Change in Hb Concentrations Between Baseline SVP and the EEP
Time frame: SVP (Week -4 to -1), EEP (Week 16 to 23)
Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP
Time frame: EEP (Week 16 to 23)
Mean Time Spent in Hb Range 10-12 g/dL
Time frame: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
Time frame: DTP (Week 0 to 15) and EEP (Week 16 to 23)
Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP
Time frame: DTP (Week 0 to 15) up to EEP (Week 16 to 23)

Results and safety

Results posted to the registry on 13 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C.E.R.A	65	48
Epoetin Alfa	36	31

Primary outcome: Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP

Time frame: EEP (Week 16 to 23). Number (95% Confidence Interval). Unit: percentage of participants

Measure	C.E.R.A n = 44	Epoetin Alfa n = 29
Value	45.45 (30.39 to 61.15)	55.17 (35.69 to 73.55)

C.E.R.A vs Epoetin Alfa: p = 0.4778, Fisher Exact

Population analysed: Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 to Week 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C.E.R.A	16 of 65 (24.6%)	11 of 65 (16.9%)	Not reported
Epoetin Alfa	4 of 36 (11.1%)	9 of 36 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26965694Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

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

19 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 and Epoetin alfa in people with Anemia, run by Hoffmann-La Roche at 19 sites in Spain.

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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. 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 13 May 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 Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP (time frame: EEP (Week 16 to 23)). 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 NCT00605293, 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 13 May 2016.