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Methoxy polyethylene glycol-epoetin beta

Generic Name
Methoxy polyethylene glycol-epoetin beta
Brand Names
Mircera
Drug Type
Biotech
Chemical Formula
-
CAS Number
677324-53-7
Unique Ingredient Identifier
LR3UXN0193
Background

Methoxy polyethylene glycol-epoetin beta is a chemically synthesised Erythropoiesis Stimulating Agent (ESA) with a longer half-life than erythropoietin. ESA is used to increase synthesis of red blood cells to treat chronic kidney disease associated anemia.

Indication

For the treatment of patients with anaemia associated with chronic kidney disease. Not a substitute for RBC transfusion if immediate correction of anemia is required.

Associated Conditions
Anemia
Associated Therapies
-

An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

Completed
Conditions
Kidney Disease, Chronic
Interventions
First Posted Date
2015-09-11
Last Posted Date
2017-06-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
393
Registration Number
NCT02547454
Locations
🇸🇮

Hospital Celje; Dept For Kidney Disease & Dialysis, Celje, Slovenia

🇸🇮

Splosna Bolnisnica Izola; Oddelek Za Nefrologijo, Izola, Slovenia

🇸🇮

Clinical Centre Ljubljana; Clinical Dep. For Nephrology, Ljubljana, Slovenia

and more 9 locations

An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis

Completed
Conditions
Chronic Kidney Diseases
Interventions
First Posted Date
2014-09-12
Last Posted Date
2017-05-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
197
Registration Number
NCT02238080
Locations
🇮🇱

Holy Family Hospital; Nephrology, Nazareth, Israel

🇮🇱

Rebecca Sief Hospital; Nephrology, Safed, Israel

🇮🇱

Sourasky MC; Dept. of Nephrology, Tel Aviv, Israel

and more 15 locations

Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

Phase 4
Completed
Conditions
Inflammation
Anemia
Malnutrition
Interventions
First Posted Date
2014-09-05
Last Posted Date
2014-09-05
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Target Recruit Count
67
Registration Number
NCT02232113
Locations
🇨🇳

Taipei Veterans General Hospital, Taipei, Taiwan

Comparison Among Erythropoietin Stimulating Agents

Phase 4
Completed
Conditions
Anemia of End Stage Renal Disease
Interventions
First Posted Date
2014-01-30
Last Posted Date
2017-09-13
Lead Sponsor
Hamad Medical Corporation
Target Recruit Count
327
Registration Number
NCT02049346
Locations
🇶🇦

Fahd Bin Jassem Dialysis Centre, Doha, Qatar

A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)

Completed
Conditions
Renal Anemia of Chronic Kidney Disease
Interventions
First Posted Date
2012-12-27
Last Posted Date
2019-07-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
551
Registration Number
NCT01756612
Locations
🇫🇷

Hopital Claude Huriez; Nephrologie, Lille, France

🇫🇷

Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse, Lyon, France

🇫🇷

Polyclinique De La Louviere; Nephrologie, Lille, France

and more 102 locations

A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis

Phase 4
Completed
Conditions
Anemia, Kidney Disease, Chronic
Interventions
First Posted Date
2012-01-27
Last Posted Date
2019-06-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
87
Registration Number
NCT01519947
Locations
🇲🇽

Unidad De Dialisis La Loma S.C., Pureto Vallarta, Mexico

🇲🇽

Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C, Aguascalientes, Mexico

🇲🇽

Nefros Investigación S.C., Delegación Coyoacan, Mexico

and more 4 locations

A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)

Phase 2
Completed
Conditions
Kidney Disease, Chronic
Interventions
First Posted Date
2010-09-02
Last Posted Date
2017-05-10
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
241
Registration Number
NCT01194154
Locations
🇩🇪

Klinikum d.Universität München Campus Großhadern, München, Germany

🇩🇪

Nierenzentrum Bogenhausen/Perlach; Praxis für Nierenheilkunde, München-Bogenhausen, Germany

🇩🇪

Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie, Berlin, Germany

and more 30 locations

A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia

Phase 3
Completed
Conditions
Anemia
Interventions
First Posted Date
2008-10-16
Last Posted Date
2016-04-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
140
Registration Number
NCT00773968

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

Phase 4
Completed
Conditions
Chronic Renal Anemia
Interventions
First Posted Date
2008-10-16
Last Posted Date
2019-08-20
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
2825
Registration Number
NCT00773513
Locations
🇦🇺

Gosford Hospital; Renal, Gosford, New South Wales, Australia

🇭🇷

General Hospital Josip Bencevic; Department of Haemodialysis, Slavonski Brod, Croatia

🇦🇺

Renal Research Dr Simon Roger, Gosford, New South Wales, Australia

and more 193 locations

A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis

Phase 3
Completed
Conditions
Anemia
Interventions
First Posted Date
2008-08-19
Last Posted Date
2017-06-23
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
96
Registration Number
NCT00737477
Locations
🇫🇷

Arauco; Arauco Tours Bretonneau, Tours, France

🇫🇷

Centre Hospitalier; Hemodialyse, Annonay, France

🇫🇷

Ch Notre Dame Misericorde; Hemodialyse, Ajaccio, France

and more 49 locations
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