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)

August 7, 2019 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

437

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alexandroupolis, Greece, 68100
        • Uni Hospital of Alexandroupoli; Nephrology Dept.
      • Athens, Greece, 11528
        • Kyanos Stavros Private Hospital; Nephrologic Clinic
      • Athens, Greece, 115 27
        • Laiko General Hospital; Nephrology Div.
      • Athens, Greece, 11526
        • Red Cross Hospital;Nephrology Dpt.
      • Athens, Greece, 11527
        • 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, 12351
        • General Hospital Of West Attikis; Nephrology
      • Athens, Greece, 124 61
        • University Hospital Attikon ; Pathology Clinic
      • Athens, Greece, 18454
        • Nikea General Hospital; Nephrologic Clinic
      • Drama, Greece, 66100
        • General Hospital Of Dramas; Dialysis Center Unit
      • Heraklion, Greece, 71110
        • University Hospital Of Heraklion; Nefrologiki Clinic
      • Ioannina, Greece, 455 00
        • Uni Hospital of Ioannina; Nephrology Dept.
      • Katerini, Greece
        • General Hospital Of Katerinis; Nephrology Unit
      • Kilkis, Greece, 611 00
        • General Hospital of Kilkis; Nephrology
      • Larissa, Greece, 41 110
        • Univeristy Hospital of Larissa; Nephrology
      • Patra, Greece, 26443
        • Olympion Therapeytirion; Nefrology
      • Patra, Greece, 26335
        • Agios Andreas General Hospital; Nephrology
      • Piraeus, Greece, 18536
        • General Hospital Tzanio ; Nephrology
      • Serres, Greece, 62100
        • General Hospital Of Serres; Nephrology
      • Thessaloniki, Greece, 54636
        • AXEPA Pathology Section; A Pathology Clinic
      • Thessaloniki, Greece, 570 01
        • Thermi Private Clinic; Nephrology
      • Thessaloniki, Greece
        • Agios Loukas Private Clinic; Nephrology
      • Volos, Greece, 38221
        • Thessaliki Nossileytiki; Nephrology
      • Xanthi, Greece
        • General Hospital of Xanthi; Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Months 8 to 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Months 8 to 10
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.
Up to 10 months
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.
Up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2013

Primary Completion (Actual)

September 4, 2016

Study Completion (Actual)

September 4, 2016

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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