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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677767
First received: August 30, 2012
Last updated: February 8, 2016
Last verified: February 2016

August 30, 2012
February 8, 2016
April 2011
September 2013   (final data collection date for primary outcome measure)
  • Mean Age of Participants Treated With C.E.R.A [ Time Frame: Baseline (Week 0) ] [ Designated as safety issue: No ]
    Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
  • Mean Weight of Participants Treated With C.E.R.A [ Time Frame: Baseline (Week 0) ] [ Designated as safety issue: No ]
    Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
  • Number of Participants With Co-morbidity Treated With C.E.R.A [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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.
  • Mean Time Required to Achieve Target Hemoglobin Range [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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
  • Percentage of Participants Achieved Target Range of Hemoglobin [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Clinical/demographic patient characteristics at initiation of treatment with Mircera [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Mean time to achieve target Hb range (Hb 10-12 g/dL) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Maintenance of Hb levels (patients on ESA with HB 10-12 g/dL): Percentage of patients maintaining Hb level within 1 g/dL of baseline during study period (24 weeks) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01677767 on ClinicalTrials.gov Archive Site
  • Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
  • Mean Time Spent by Participants in the Hb Target Range [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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.
  • Evaluation of Route of Administration for C.E.R.A [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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.
  • Evaluation of Dose Per Injection of C.E.R.A [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Received Concomitant Medications [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    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.
  • Percentage of patients achieving Hb target range (Hb 10-12 g/dL) at least once during study treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Maintenance: Mean time spent on Hb level 10-12 g/dL [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Dosage/administration route [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
Anemia
Not Provided
Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01677767
ML25475
Not Provided
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP