A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
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)
2 other identifiers
interventional
241
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Typical duration for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedStudy Start
First participant enrolled
September 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2015
CompletedResults Posted
Study results publicly available
June 14, 2016
CompletedMay 10, 2017
April 1, 2017
4.5 years
August 25, 2010
March 16, 2016
April 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)
The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m\^2) = 175 x Serum Cr\^-1.154 x age\^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m\^2 / Year) is defined as -365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.
24 months
Secondary Outcomes (6)
Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
24 months
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24
Baseline, Month 24
Change From Baseline in Serum Creatinine Concentration at Month 24
Baseline, Month 24
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24
Baseline, Month 24
Change From Baseline in Serum Cystatin C Concentration at Month 24
Baseline, Month 24
- +1 more secondary outcomes
Study Arms (2)
Mircera
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
Aachen, 52057, Germany
Dialysepraxis Dr. Stallforth, Dr. Kirschner, Dr. Al-Sarraf und Dr. Pawlik
Augsburg, 86157, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. im Kurhaus
Bad König, 64732, Germany
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, 10117, Germany
Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I
Berlin, 12203, Germany
Gemeinschaftspraxis Dres. Erika Eger, Frank Seibt, Oliver Eike u.w. - Dialysezentrum Treptower Park
Berlin, 12435, Germany
Dialyse-Institut Bovenden
Bovenden, 37120, Germany
Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
Cologne, 51109, Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden, 01307, Germany
DaVita Clinical Research Deutschland GmbH
Düsseldorf, 40210, Germany
Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie
Essen, 45122, Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III
Frankfurt, 60596, Germany
Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Dialysepraxis Prof.Dr.med. Michael Rambausek Dres. Stephan Matthias und Gabriele Kunowski - Dialysz.
Heilbronn, 74076, Germany
Nephrologisches Zentrum Hilden am St. Josefs-Krankenhaus
Hilden, 40724, Germany
Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
Homburg/Saar, 66424, Germany
Dres. Jan Nawka und Frank Pistrosch
Hoyerswerda, 02977, Germany
Westpfalz-Klinikum Gmbh; Nephrologie/Transplantationsmedizin
Kaiserslautern, 67655, Germany
PHV Patienten-Heimversorgung Dialyse-Station
Kiel, 24106, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum
Lübeck, 23562, Germany
Gemienschaftspraxis Dres. Leistikow, Rachti & Sandner
Mannheim, 68309, Germany
Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
Mettmann, 40822, Germany
Klinikum Innenstadt Medizinische Klinik; Abt.Endokrinologie und Diabetologie
München, 80336, Germany
Klinikum d.Universität München Campus Großhadern
München, 81377, Germany
Nierenzentrum Bogenhausen/Perlach; Praxis für Nierenheilkunde
München-Bogenhausen, 81925, Germany
Universitätsklinikum Münster Innere Medizin D
Münster, 48149, Germany
Dres. Georg Fuchs und Nexhat Miftari
Neckarsulm, 74172, Germany
Nephrologische Praxis Neunkirchen - Dr.med. Klemens Dorr und Artem Goldmann
Neunkirchen/Saar, 66538, Germany
Dialysezentrum Saarlouis
Saarlouis, 66740, Germany
Gemeinschaftspraxis Rosemarie Krämer und Lars Rothermund
Ulm, 89077, Germany
Nephrologisches Zentrum
Velbert, 42549, Germany
Nephrologisches Zentrum Dialyse-Institut
Villingen-Schwenningen, 78052, Germany
KfH Kuratiorium für Dialyse und Nierentransplantation e.V.
Wiesbaden, 65191, Germany
Related Publications (1)
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.
PMID: 36791280DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2010
First Posted
September 2, 2010
Study Start
September 30, 2010
Primary Completion
March 31, 2015
Study Completion
March 31, 2015
Last Updated
May 10, 2017
Results First Posted
June 14, 2016
Record last verified: 2017-04