Last reviewed · How we verify
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Phase 4 trial testing methoxy polyethylene glycol-epoetin beta in Anemia in 35 participants. Completed in 31 December 2009.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 30 June 2008 |
| Primary completion | 31 December 2009 |
| Estimated completion | 31 December 2009 |
| Sites | 32 locations across Belgium |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
| Group | Value | 95% CI |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | 41 | 24.7 – 59.3 |
The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
| Group | Value | 95% CI |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | 0.99 | ± 1.38 |
| Group | Value | 95% CI |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | 23.5 | 10.8 – 41.2 |
| Group | Value | 95% CI |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | 28.6 | ± 21.2 |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | 97 |
Time frame: Weeks 1-40. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Methoxy Polyethylene Glyco… |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Renal failure chronic | Renal and urinary disorders | — |
| Pancytopenia | Blood and lymphatic system disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Oesophagitis | Gastrointestinal disorders | — |
| Administration related reaction | General disorders | — |
| Asthenia | General disorders | — |
| Medical device complication | General disorders | — |
| Pyrexia | General disorders | — |
| Sudden cardiac death | General disorders | — |
| Hepatic cirrhosis | Hepatobiliary disorders | — |
| Diarrhoea infectious | Infections and infestations | — |
| Gastroenteritis | Infections and infestations | — |
| Pseudomembranous colitis | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Carotid artery stenosis | Nervous system disorders | — |
| Renal failure acute | Renal and urinary disorders | — |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | — |
| Extremity necrosis | Vascular disorders | — |
| Reaction | System | Methoxy Polyethylene Glyco… |
|---|---|---|
| Hypertension | Vascular disorders | — |
| Bronchitis | Infections and infestations | — |
| Fatigue | General disorders | — |
| Oedema | General disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Nasopharyngitis | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Gastric ulcer | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Oesophagitis | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Gastroenteritis | Infections and infestations | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Anaemia, Cardiac failure, Renal failure chronic, Pancytopenia, Cardiac arrest, Cardiac failure congestive, Myocardial infarction, Diarrhoea.
Data from ClinicalTrials.gov NCT00642668 adverse events section.
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00642668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing