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OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis (OPTIMA)

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ClinicalTrials.gov Identifier: NCT01902628
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : August 7, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

Condition or disease
Anemia

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Study Type : Observational
Actual Enrollment : 437 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)
Actual Study Start Date : July 15, 2013
Actual Primary Completion Date : September 4, 2016
Actual Study Completion Date : September 4, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Participants with CKD
This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.



Primary Outcome Measures :
  1. Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 [ Time Frame: Months 8 to 10 ]
    g/dL = grams per deciliter


Secondary Outcome Measures :
  1. Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 [ Time Frame: Months 8 to 10 ]
    g/dL = grams per deciliter

  2. Percentage of Participants With MIRCERA Dose Adjustments [ Time Frame: Up to 10 months ]
    Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.

  3. Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs [ Time Frame: Up to 10 months ]
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4) initiated on Mircera therapy
Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4)
  • Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
  • Life expectancy > 10 months

Exclusion Criteria:

  • Malignant disease
  • Significant or acute bleeding
  • Poorly controlled hypertension
  • Blood transfusion during the previous 2 months
  • Hypersensitivity to Mircera or any of its excipients

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): NCT01902628


Locations
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Greece
Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupolis, Greece, 68100
Laiko General Hospital; Nephrology Div.
Athens, Greece, 115 27
Red Cross Hospital;Nephrology Dpt.
Athens, Greece, 11526
General Hospital Of Athens G.Gennimatas; Nephrology
Athens, Greece, 11527
Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center
Athens, Greece, 11527
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, Greece, 11528
General Hospital Of West Attikis; Nephrology
Athens, Greece, 12351
University Hospital Attikon ; Pathology Clinic
Athens, Greece, 124 61
Nikea General Hospital; Nephrologic Clinic
Athens, Greece, 18454
General Hospital Of Dramas; Dialysis Center Unit
Drama, Greece, 66100
University Hospital Of Heraklion; Nefrologiki Clinic
Heraklion, Greece, 71110
Uni Hospital of Ioannina; Nephrology Dept.
Ioannina, Greece, 455 00
General Hospital Of Katerinis; Nephrology Unit
Katerini, Greece
General Hospital of Kilkis; Nephrology
Kilkis, Greece, 611 00
Univeristy Hospital of Larissa; Nephrology
Larissa, Greece, 41 110
Agios Andreas General Hospital; Nephrology
Patra, Greece, 26335
Olympion Therapeytirion; Nefrology
Patra, Greece, 26443
General Hospital Tzanio ; Nephrology
Piraeus, Greece, 18536
General Hospital Of Serres; Nephrology
Serres, Greece, 62100
AXEPA Pathology Section; A Pathology Clinic
Thessaloniki, Greece, 54636
Thermi Private Clinic; Nephrology
Thessaloniki, Greece, 570 01
Agios Loukas Private Clinic; Nephrology
Thessaloniki, Greece
Thessaliki Nossileytiki; Nephrology
Volos, Greece, 38221
General Hospital of Xanthi; Nephrology
Xanthi, Greece
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01902628     History of Changes
Other Study ID Numbers: ML28261
First Posted: July 18, 2013    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 9, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency