A Phase 3 interventional study of Methoxy Polyethylene Glycol-epoetin Beta in Anemia, sponsored by Hoffmann-La Roche. Terminated at 22 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 39 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases 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.
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Exclusion Criteria:
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Drug: Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Also known as: Mircera, RO0503821
Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
Time frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
Time to Achievement of Response
Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.
Time frame: Baseline to Week 40
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.
Time frame: EEP (Weeks 29 to 36)
Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.
Time frame: EEP (Weeks 29 to 36)
Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.
Time frame: EEP (Weeks 29 to 36)
| Milestone | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Started | 39 |
| Completed | 30 |
| Not completed | 9 |
| Withdrew: Adverse event | 2 |
| Withdrew: Death | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Other | 4 |
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
| grams per deciliter (g/dL) | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) | 1.32 ± 0.88 |
Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.
| days | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Time to Achievement of Response | 24.6 ± 20.53 |
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.
| percentage of participants | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP | 53.9 |
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.
| percentage of participants | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP | 66.7 |
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.
| days | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP | 42.5 ± 13.96 |
Collected over Baseline up to Week 40. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | — | 11/39 (28.2%) | 11/39 (28.2%) |
| Event | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Angina pectorisCardiac disorders | 1/39 |
| Arteriosclerosis coronary arteryCardiac disorders | 1/39 |
| Atrial fibrillationCardiac disorders | 1/39 |
| BronchitisInfections and infestations | 1/39 |
| Otitis media chronicInfections and infestations | 1/39 |
| PneumoniaInfections and infestations | 1/39 |
| Postoperative wound infectionInfections and infestations | 1/39 |
| Iron deficiencyMetabolism and nutrition disorders | 1/39 |
| Back painMusculoskeletal and connective tissue disorders | 1/39 |
| Intra-uterine deathPregnancy, puerperium and perinatal conditions | 1/39 |
| Event | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| HypertensionVascular disorders | 5/39 |
| Urinary tract infectionInfections and infestations | 4/39 |
| InsomniaPsychiatric disorders | 2/39 |
| Urine odour abnormalRenal and urinary disorders | 2/39 |
Safety population: included all participants who were treated with at least one dose of the study medication.
| Age, Continuous(years) | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Mean | 61.6 ± 18.25 |
| Sex: Female, Male(Participants) | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Female | 28 |
| Male | 11 |
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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