A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
NCT ID: NCT01194154
Last Updated: 2017-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
241 participants
INTERVENTIONAL
2010-09-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mircera
Methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
Placebo
Placebo
Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
Interventions
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Methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
Placebo
Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For renal allograft recipients: Status at least 6 months post transplantation
* Chronic kidney disease stage III
* Urinary albumin-to-creatinine ratio less than (\<) 3000 milligram (mg)/gram (g) or total protein \<3000 mg/ 24 hour urine sample where applicable
Exclusion Criteria
* Average systolic blood pressure (SBP) \> 140 millimeter of mercury (mm Hg) or average diastolic blood pressure (DBP) \> 90 mm Hg
* Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
* Present and known iron deficiency
* HbA1c \>9%
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
Aachen, , Germany
Dialysepraxis Dr. Stallforth, Dr. Kirschner, Dr. Al-Sarraf und Dr. Pawlik
Augsburg, , Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. im Kurhaus
Bad König, , Germany
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, , Germany
Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I
Berlin, , Germany
Gemeinschaftspraxis Dres. Erika Eger, Frank Seibt, Oliver Eike u.w. - Dialysezentrum Treptower Park
Berlin, , Germany
Dialyse-Institut Bovenden
Bovenden, , Germany
Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
Cologne, , Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden, , Germany
DaVita Clinical Research Deutschland GmbH
Düsseldorf, , Germany
Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie
Essen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III
Frankfurt, , Germany
Uniklinikum Heidelberg
Heidelberg, , Germany
Dialysepraxis Prof.Dr.med. Michael Rambausek Dres. Stephan Matthias und Gabriele Kunowski - Dialysz.
Heilbronn, , Germany
Nephrologisches Zentrum Hilden am St. Josefs-Krankenhaus
Hilden, , Germany
Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
Homburg/Saar, , Germany
Dres. Jan Nawka und Frank Pistrosch
Hoyerswerda, , Germany
Westpfalz-Klinikum Gmbh; Nephrologie/Transplantationsmedizin
Kaiserslautern, , Germany
PHV Patienten-Heimversorgung Dialyse-Station
Kiel, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum
Lübeck, , Germany
Gemienschaftspraxis Dres. Leistikow, Rachti & Sandner
Mannheim, , Germany
Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
Mettmann, , Germany
Klinikum Innenstadt Medizinische Klinik; Abt.Endokrinologie und Diabetologie
München, , Germany
Klinikum d.Universität München Campus Großhadern
München, , Germany
Nierenzentrum Bogenhausen/Perlach; Praxis für Nierenheilkunde
München-Bogenhausen, , Germany
Universitätsklinikum Münster Innere Medizin D
Münster, , Germany
Dres. Georg Fuchs und Nexhat Miftari
Neckarsulm, , Germany
Nephrologische Praxis Neunkirchen - Dr.med. Klemens Dorr und Artem Goldmann
Neunkirchen/Saar, , Germany
Dialysezentrum Saarlouis
Saarlouis, , Germany
Gemeinschaftspraxis Rosemarie Krämer und Lars Rothermund
Ulm, , Germany
Nephrologisches Zentrum
Velbert, , Germany
Nephrologisches Zentrum Dialyse-Institut
Villingen-Schwenningen, , Germany
KfH Kuratiorium für Dialyse und Nierentransplantation e.V.
Wiesbaden, , Germany
Countries
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References
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Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Other Identifiers
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2009-015114-22
Identifier Type: -
Identifier Source: secondary_id
ML22916
Identifier Type: -
Identifier Source: org_study_id
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