An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

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. Identifier: NCT01677767
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : February 5, 2016
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Condition or disease

Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice
Actual Study Start Date : April 30, 2011
Actual Primary Completion Date : September 30, 2013
Actual Study Completion Date : September 30, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia


Primary Outcome Measures :
  1. Mean Age of Participants Treated With C.E.R.A [ Time Frame: Baseline (Week 0) ]
    Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25

  2. Mean Weight of Participants Treated With C.E.R.A [ Time Frame: Baseline (Week 0) ]
    Weight of the participants was measured at the Baseline and summarized with descriptive statistics.

  3. Number of Participants With Co-morbidity Treated With C.E.R.A [ Time Frame: Up to Week 24 ]
    Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.

  4. Mean Time Required to Achieve Target Hemoglobin Range [ Time Frame: Up to Week 24 ]
    The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1

  5. Percentage of Participants Achieved Target Range of Hemoglobin [ Time Frame: Up to Week 24 ]
    The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.

  6. Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. [ Time Frame: Up to Week 24 ]
    Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.

Secondary Outcome Measures :
  1. Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study [ Time Frame: Up to Week 24 ]
    For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.

  2. Mean Time Spent by Participants in the Hb Target Range [ Time Frame: Up to Week 24 ]
    Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.

  3. Evaluation of Route of Administration for C.E.R.A [ Time Frame: Up to Week 24 ]
    C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.

  4. Evaluation of Dose Per Injection of C.E.R.A [ Time Frame: Up to Week 24 ]
    The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.

  5. Number of Participants Received Concomitant Medications [ Time Frame: Up to Week 24 ]
    Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age, inclusive
  • Patients with chronic kidney disease on dialysis
  • ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
  • Adequate irons status as judged by the treating physician

Exclusion Criteria:

  • Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
  • Clinically significant concomitant disease or disorder as defined by protocol
  • Clinical suspicion of pure red cell aplasia (PRCA)
  • Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
  • Transfusion of red blood cells in the previous 2 months
  • Pregnant women
  • Contraindications for Mircera according to local prescribing information or as judged by the investigator

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 identifier (NCT number): NCT01677767

Sir Gangaram Hospital
New Delhi, Delhi, India, 110060
Ahmedabad Dialysis Centre
Ahmedabad, India, 380005
Excel Center
Guwahati, India, 781007
ESIS Hospital; Department of Nephrology
Kolkata, India, 600054
Vertex Hospital
Mumbai, India, 400083
Apollo Indraprastha Hospitals; Nephrology
New Delhi, India, 110076
Aditya Birla Memorial Hospital
Pune, India, 411033
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01677767     History of Changes
Other Study ID Numbers: ML25475
First Posted: September 3, 2012    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: July 5, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Hematologic Diseases