A Phase 3 interventional study of Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) in Anemia, sponsored by Hoffmann-La Roche. Completed at 60 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 351 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
Also known as: Mircera
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference 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 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis 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.
Time frame: Week 17 up to Week 24
Change in Hemoglobin Concentration Between Reference SVP and EEP
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.
Time frame: Week -4 up to Week 0 and Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Time frame: Week 17 up to Week 24
Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Time frame: 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.
Time frame: Week 1 up to Week 16 and Week 17 up to Week 24
Number of Participants With Red Blood Cell Transfusion During the Study
Number of participant who underwent red blood cell transfusion during the study was reported.
Time frame: Week -4 up to Week 52
| Milestone | C.E.R.A. |
|---|---|
| Started | 351 |
| Completed | 261 |
| Not completed | 90 |
| Withdrew: Death | 6 |
| Withdrew: Adverse event | 15 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Protocol violation | 10 |
| Withdrew: Lack of efficacy | 8 |
| Withdrew: Failure to return | 1 |
| Withdrew: Blood transfusion | 24 |
| Withdrew: Renal transplantation | 10 |
| Withdrew: Other | 5 |
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis 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.
| percentage of participants | C.E.R.A. |
|---|---|
| Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range | 60.00 (52.10 to 67.54) |
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.
| g/dL | C.E.R.A. |
|---|---|
| Change in Hemoglobin Concentration Between Reference SVP and EEP | -0.10 ± 0.98 |
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
| percentage of participants | C.E.R.A. |
|---|---|
| Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range | 73.94 (66.54 to 80.45) |
Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
| days | C.E.R.A. |
|---|---|
| Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | 44.0 (0.0 to 56.0) |
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.
| percentage of participants | C.E.R.A. |
|---|---|
| DTP | 70.3 |
| EEP | 50.9 |
Number of participant who underwent red blood cell transfusion during the study was reported.
| participants | C.E.R.A. |
|---|---|
| Number of Participants With Red Blood Cell Transfusion During the Study | 38 |
Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| C.E.R.A. | — | 98/351 (27.9%) | 23/351 (6.6%) |
| Event | C.E.R.A. |
|---|---|
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 9/351 |
| AnaemiaBlood and lymphatic system disorders | 7/351 |
| Transient ischaemic attackNervous system disorders | 4/351 |
| Acute pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 4/351 |
| Peripheral ischaemiaVascular disorders | 4/351 |
| Myocardial infarctionCardiac disorders | 3/351 |
| PyrexiaGeneral disorders | 3/351 |
| PneumoniaInfections and infestations | 3/351 |
| Vascular access complicationInjury, poisoning and procedural complications | 3/351 |
| Haemoglobin decreasedInvestigations | 3/351 |
| Event | C.E.R.A. |
|---|---|
| HypertensionVascular disorders | 23/351 |
The safety population included all participants who were treated with at least 1 dose of C.E.R.A. and had a safety follow-up, whether withdrawn prematurely or not.
| Age, Continuous(years) | C.E.R.A. |
|---|---|
| Mean | 65.7 ± 13.32 |
| Sex: Female, Male(Participants) | C.E.R.A. |
|---|---|
| Female | 149 |
| Male | 202 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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