AnemiaPhase 3NCT00576628
A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [C.E.R.A.] in people with Anemia, run by Hoffmann-La Roche at 19 sites in Russia.
Trial summary
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. 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.]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 19 sitesRussia
- Study dates
- May 2008to Mar 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
- adult patients, >=18 years of age;
- chronic renal anemia, with no need for dialysis expected in next 3 months;
- adequate iron status.
Who cannot join
- previous epoetin therapy within 12 weeks prior to treatment;
- transfusion of red blood cells during 2 months prior to screening;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B 12 deficiency.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Study site
Irkutsk, 664079
Study site
Khanty-Mansiysk, 628011
Study site
Moscow, 117036
Study site
Moscow, 123182
Study site
Moscow, 125101
Study site
Moscow, 129110
Study site
Nizhny Novgorod, 603001
Study site
Nizhny Novgorod, 603126
Study site
Omsk, 644112
Study site
Orenburg, 460018
Study site
Rostov-on-Don, 344029
Study site
Saint Petersburg, 194354
Study site
Saint Petersburg, 195067
Study site
Saint Petersburg, 197089
Study site
Saint Petersburg, 197110
Study site
Saratov, 410053
Study site
Tyumen, 625023
Study site
Ufa, 450005
Study site
Yekaterinburg, 620102
About this study
Official title: A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- 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
Recommended starting dose 1.2 micrograms/kg sc monthly
| Study group | Role | What they receive |
|---|---|---|
| C.E.R.A | Experimental | Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range. 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.
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.
Measured: Baseline (Week 0) and from Week 29 to Week 36
Secondary outcomes (16)
Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP
Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.
Measured: From Week 29 to Week 36
Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period
The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.
Measured: From Week 29 to Week 36
The Number of Participants Who Required Dose Adjustments During the Dose Titration Period
The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.
Measured: From Week 0 to Week 28 (DTP)
Time to Achievement of Response During the Efficacy Evaluation Period
The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.
Measured: From Week 29 to Week 36
Number of Participants With Red Blood Cells Transfusions.
The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.
Measured: Up to Week 52
Mean Values of Laboratory Parameter : Hb Concentration
The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Hematocrit
Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration
The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity
The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Serum Creatinine
The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.
Measured: Baseline (Week 0), and Week 32
Mean Values of Laboratory Parameter: C Reactive Protein
The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration
The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter: Ferritin Concentration
The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count
The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: Transferrin Saturation
The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.
Measured: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.
Measured: From Week 29 to Week 36 (EEP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 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.
- 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
- 133 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
- NCT00576628
- Sponsor's protocol ID
- ML20978
- Status last verified
- Oct 2016
- First submitted
- 18 Dec 2007
- Last updated
- 30 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA
- ClinicalTrials.gov ID
- NCT00576628
- Acronym / sponsor ID
- ML20978
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 30 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, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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.]Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, >=18 years of age;
- chronic renal anemia, with no need for dialysis expected in next 3 months;
- adequate iron status.
Key exclusion criteria (5 listed)
- previous epoetin therapy within 12 weeks prior to treatment;
- transfusion of red blood cells during 2 months prior to screening;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B 12 deficiency.
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.]Recommended starting dose 1.2 micrograms/kg sc monthly | Drug | C.E.R.A |
Primary outcome
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
Time frame: Baseline (Week 0) and from Week 29 to Week 36
The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.
16 secondary outcomes
Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP
Time frame: From Week 29 to Week 36
Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period
Time frame: From Week 29 to Week 36
The Number of Participants Who Required Dose Adjustments During the Dose Titration Period
Time frame: From Week 0 to Week 28 (DTP)
Time to Achievement of Response During the Efficacy Evaluation Period
Time frame: From Week 29 to Week 36
Number of Participants With Red Blood Cells Transfusions.
Time frame: Up to Week 52
Mean Values of Laboratory Parameter : Hb Concentration
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Hematocrit
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Serum Creatinine
Time frame: Baseline (Week 0), and Week 32
Mean Values of Laboratory Parameter: C Reactive Protein
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter: Ferritin Concentration
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: Transferrin Saturation
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
Time frame: From Week 29 to Week 36 (EEP)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- 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
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 [C.E.R.A.] in people with Anemia, run by Hoffmann-La Roche at 19 sites in Russia.
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 5 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 30 Nov 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 Russia. 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 30 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?
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period (time frame: Baseline (Week 0) and from Week 29 to Week 36). 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 30 Nov 2016.