Clinical trial NCT01194154: A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
Official title: A Randomized Controlled, Single-blind, Proof-of-concept-study to Investigate the Protective Effects of Early Treatment With C.E.R.A. in Patients With Chronic Kidney Disease on Renal Disease Progression (PRIMAVERA-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with Mircera in participants with chronic kidney disease on renal disease progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated time on study treatment is 24 months.


Eligibility criteria: Inclusion Criteria:

* For diabetic participants: Type 2 diabetes mellitus with glycated hemoglobin (HbA1c) greater than (\>) 7% or anti-diabetic treatment
* 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:

* Hemoglobin-level \< 11 or \> 14 g/deciliter (dL)
* 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%

Primary outcomes:
measure: Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)
timeFrame: 24 months
Secondary outcomes:
measure: Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
timeFrame: 24 months
measure: Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Serum Creatinine Concentration at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Serum Cystatin C Concentration at Month 24
timeFrame: Baseline, Month 24
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 24 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
city: Augsburg
country: Germany
facility: Dialysepraxis Dr. Stallforth, Dr. Kirschner, Dr. Al-Sarraf und Dr. Pawlik
city: Bad König
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V. im Kurhaus
city: Berlin
country: Germany
facility: Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I
city: Berlin
country: Germany
facility: Gemeinschaftspraxis Dres. Erika Eger, Frank Seibt, Oliver Eike u.w. - Dialysezentrum Treptower Park
city: Bovenden
country: Germany
facility: Dialyse-Institut Bovenden
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Deutschland GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III
city: Heidelberg
country: Germany
facility: Uniklinikum Heidelberg
city: Heilbronn
country: Germany
facility: Dialysepraxis Prof.Dr.med. Michael Rambausek Dres. Stephan Matthias und Gabriele Kunowski - Dialysz.
city: Hilden
country: Germany
facility: Nephrologisches Zentrum Hilden am St. Josefs-Krankenhaus
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
city: Hoyerswerda
country: Germany
facility: Dres. Jan Nawka und Frank Pistrosch
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum Gmbh; Nephrologie/Transplantationsmedizin
city: Kiel
country: Germany
facility: PHV Patienten-Heimversorgung Dialyse-Station
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum
city: Mannheim
country: Germany
facility: Gemienschaftspraxis Dres. Leistikow, Rachti & Sandner
city: Mettmann
country: Germany
facility: Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
city: Muenchen
country: Germany
facility: Klinikum Innenstadt Medizinische Klinik; Abt.Endokrinologie und Diabetologie
city: München-Bogenhausen
country: Germany
facility: Nierenzentrum Bogenhausen/Perlach; Praxis für Nierenheilkunde
city: München
country: Germany
facility: Klinikum d.Universität München Campus Großhadern
city: Münster
country: Germany
facility: Universitätsklinikum Münster Innere Medizin D
city: Neckarsulm
country: Germany
facility: Dres. Georg Fuchs und Nexhat Miftari
city: Neunkirchen/Saar
country: Germany
facility: Nephrologische Praxis Neunkirchen - Dr.med. Klemens Dorr und Artem Goldmann
city: Saarlouis
country: Germany
facility: Dialysezentrum Saarlouis
city: Ulm
country: Germany
facility: Gemeinschaftspraxis Rosemarie Krämer und Lars Rothermund
city: Velbert
country: Germany
facility: Nephrologisches Zentrum
city: Villingen-Schwenningen
country: Germany
facility: Nephrologisches Zentrum Dialyse-Institut
city: Wiesbaden
country: Germany
facility: KfH Kuratiorium für Dialyse und Nierentransplantation e.V.
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: