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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194154
First Posted: September 2, 2010
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Kidney Disease, Chronic Drug: Methoxy polyethylene glycol-epoetin beta Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4) [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures:
  • Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) [ Time Frame: 24 months ]
    The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 141 x min (SerumCr/k; 1)^a x max(SerumCr/k; 1)^(-1.209) x 0.993^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m^2 / Year) is defined as -365.25 x Beta, where Beta is the slope parameter derived for each participant 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.

  • Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24 [ Time Frame: Baseline, Month 24 ]
    Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function.

  • Change From Baseline in Serum Creatinine Concentration at Month 24 [ Time Frame: Baseline, Month 24 ]
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent.

  • Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24 [ Time Frame: Baseline, Month 24 ]
    UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.

  • Change From Baseline in Serum Cystatin C Concentration at Month 24 [ Time Frame: Baseline, Month 24 ]
    Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.

  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 24 months ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.


Enrollment: 241
Actual Study Start Date: September 30, 2010
Study Completion Date: March 31, 2015
Primary Completion Date: March 31, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mircera Drug: 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).
Other Name: Mircera, C.E.R.A.
Placebo Comparator: Placebo Drug: Placebo
Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194154


Locations
Germany
Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
Aachen, Germany, 52057
Dialysepraxis Dr. Stallforth, Dr. Kirschner, Dr. Al-Sarraf und Dr. Pawlik
Augsburg, Germany, 86157
KfH Kuratorium für Dialyse und Nierentransplantation e.V. im Kurhaus
Bad König, Germany, 64732
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, Germany, 10117
Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I
Berlin, Germany, 12203
Gemeinschaftspraxis Dres. Erika Eger, Frank Seibt, Oliver Eike u.w. - Dialysezentrum Treptower Park
Berlin, Germany, 12435
Dialyse-Institut Bovenden
Bovenden, Germany, 37120
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden, Germany, 01307
DaVita Clinical Research Deutschland GmbH
Düsseldorf, Germany, 40210
Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie
Essen, Germany, 45122
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III
Frankfurt, Germany, 60596
Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Dialysepraxis Prof.Dr.med. Michael Rambausek Dres. Stephan Matthias und Gabriele Kunowski - Dialysz.
Heilbronn, Germany, 74076
Nephrologisches Zentrum Hilden am St. Josefs-Krankenhaus
Hilden, Germany, 40724
Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
Homburg/Saar, Germany, 66424
Dres. Jan Nawka und Frank Pistrosch
Hoyerswerda, Germany, 02977
Westpfalz-Klinikum Gmbh; Nephrologie/Transplantationsmedizin
Kaiserslautern, Germany, 67655
PHV Patienten-Heimversorgung Dialyse-Station
Kiel, Germany, 24106
Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
Köln, Germany, 51109
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum
Lübeck, Germany, 23562
Gemienschaftspraxis Dres. Leistikow, Rachti & Sandner
Mannheim, Germany, 68309
Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
Mettmann, Germany, 40822
Klinikum Innenstadt Medizinische Klinik; Abt.Endokrinologie und Diabetologie
Muenchen, Germany, 80336
Nierenzentrum Bogenhausen/Perlach; Praxis für Nierenheilkunde
München-Bogenhausen, Germany, 81925
Klinikum d.Universität München Campus Großhadern
München, Germany, 81377
Universitätsklinikum Münster Innere Medizin D
Münster, Germany, 48149
Dres. Georg Fuchs und Nexhat Miftari
Neckarsulm, Germany, 74172
Nephrologische Praxis Neunkirchen - Dr.med. Klemens Dorr und Artem Goldmann
Neunkirchen/Saar, Germany, 66538
Dialysezentrum Saarlouis
Saarlouis, Germany, 66740
Gemeinschaftspraxis Rosemarie Krämer und Lars Rothermund
Ulm, Germany, 89077
Nephrologisches Zentrum
Velbert, Germany, 42549
Nephrologisches Zentrum Dialyse-Institut
Villingen-Schwenningen, Germany, 78052
KfH Kuratiorium für Dialyse und Nierentransplantation e.V.
Wiesbaden, Germany, 65191
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194154     History of Changes
Other Study ID Numbers: ML22916
2009-015114-22
First Submitted: August 25, 2010
First Posted: September 2, 2010
Results First Submitted: March 16, 2016
Results First Posted: June 14, 2016
Last Update Posted: May 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Chronic Disease
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes
Epoetin Alfa
Hematinics