AnemiaPhase 3NCT00517881

Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) in people with Anemia, run by Hoffmann-La Roche at 14 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 (C.E.R.A.)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 14 sitesSweden
Study dates: Jun 2007to Nov 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
Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Who cannot join

Transfusion of red blood cells during previous 2 months
Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
Acute or chronic bleeding
Active malignant disease (except non-melanoma skin cancer)

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Sweden14 sites

Study site
Danderyd, 18288
Study site
Eksjö, 57581
Study site
Eskilstuna, 63188
Study site
Gävle, 80187
Study site
Gothenburg, 41345
Study site
Gothenburg, S-402 76
Study site
Huddinge, 14186
Study site
Jönköping, 55185
Study site
Kristianstad, 29185
Study site
Skellefteå, S-931 86
Study site
Stockholm, 17176
Study site
Umeå, 90185
Study site
Värnamo, 33185
Study site
Västervik, 59381

Other trials in Sweden

About this study

Official title: A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia

This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa 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
Also called Mircera
Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.

Study groups in NCT00517881
Study group	Role	What they receive
C.E.R.A.	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 Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.
Measured: Week 17 up to Week 24

Secondary outcomes (6)

Change in Hemoglobin Concentration Between Reference (SVP) and EEP
The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.
Measured: Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.
Measured: Week 17 up to Week 24
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.
Measured: Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment
Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Measured: Week 1 up to Week 16 and Week 17 up to Week 24
Percentage of Participants With Red Blood Cell Transfusion During the Study
Percentage of participant who required red blood cell transfusion during the study was reported.
Measured: Week 0 up to Week 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
Measured: Week 0 up to Week 24

Timeline

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

Jun 2007Nov 2009

First posted17 Aug 2007 (estimated)
Study startJun 2007
Primary completionNov 2009
Study completionNov 2009

Why it stopped: The study was terminated due to the slow recruitment rate.

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: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00517881
Sponsor's protocol ID: ML20944
Other IDs: 2006-006523-40
Status last verified: Apr 2016
First submitted: 16 Aug 2007
Last updated: 27 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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
Active, not recruitingObservational study
A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia
Renal Anemia

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia
ClinicalTrials.gov ID: NCT00517881
Acronym / sponsor ID: ML20944
Conditions: Anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to the slow recruitment rate.
Enrolment: 29 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 17 Aug 2007 (estimated)
Results: Posted 27 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
C.E.R.A.	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 (4 listed)

Chronic renal anemia
Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Key exclusion criteria (4 listed)

Transfusion of red blood cells during previous 2 months
Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
Acute or chronic bleeding
Active malignant disease (except non-melanoma skin cancer)

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.)Also: MirceraSubcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.	Drug	C.E.R.A.

Primary outcome

Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
Time frame: Week 17 up to Week 24
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.

6 secondary outcomes

Change in Hemoglobin Concentration Between Reference (SVP) and EEP
Time frame: Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Time frame: Week 17 up to Week 24
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Time frame: Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment
Time frame: Week 1 up to Week 16 and Week 17 up to Week 24
Percentage of Participants With Red Blood Cell Transfusion During the Study
Time frame: Week 0 up to Week 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Week 0 up to Week 24

Results and safety

Results posted to the registry on 27 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.	29	24

Primary outcome: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range

Time frame: Week 17 up to Week 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	C.E.R.A. n = 29
Value	51.7 (32.5 to 70.6)

Population analysed: The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 up to Week 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C.E.R.A.	9 of 29 (31%)	10 of 29 (34.5%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early due to the slow recruitment rate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anemia

RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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
Active, not recruitingObservational study
A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia
Renal Anemia

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

14 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 14 sites in Sweden.

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 4 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: stopped early, as of the sponsor's last update on 27 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 14 sites in Sweden. 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 27 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 Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range (time frame: Week 17 up to Week 24). 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 NCT00517881.

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 27 May 2016.