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A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis

Primary Purpose

Anemia

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Cohort
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Anemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age inclusive
  • Patients with chronic kidney disease Stage III-IV not on dialysis
  • Hb < 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
  • Adequate iron status as judged by the treating physician

Exclusion Criteria:

  • Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
  • Significant acute or chronic bleeding
  • Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
  • Active malignant disease during the last five years (except non-melanoma skin cancer)
  • Uncontrolled or symptomatic secondary hyperparathyroidism
  • Epileptic seizure during the last 6 months
  • Poorly controlled hypertension (sitting blood pressure > 170/100 mmHG)
  • Myocardial infarction or stroke, or severe or unstable CAD
  • Severe liver disease during the previous 6 months
  • Congestive heart failure NYHA Class III-IV
  • Diagnosis or suspicion of pure red cell aplasia (PRCA)
  • Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
  • Transfusion of red blood cells during the previous 2 months
  • Pregnant women
  • Any contra-indications to Mircera

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2013
    Last Updated
    October 26, 2016
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01892202
    Brief Title
    A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis
    Official Title
    Efficacy of C.E.R.A for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    No longer available
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    February 2011 (Anticipated)
    Study Completion Date
    February 2011 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hoffmann-La Roche

    4. Oversight

    5. Study Description

    Brief Summary
    This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Cohort

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients, 18 to 65 years of age inclusive Patients with chronic kidney disease Stage III-IV not on dialysis Hb < 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels) Adequate iron status as judged by the treating physician Exclusion Criteria: Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication Significant acute or chronic bleeding Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) Active malignant disease during the last five years (except non-melanoma skin cancer) Uncontrolled or symptomatic secondary hyperparathyroidism Epileptic seizure during the last 6 months Poorly controlled hypertension (sitting blood pressure > 170/100 mmHG) Myocardial infarction or stroke, or severe or unstable CAD Severe liver disease during the previous 6 months Congestive heart failure NYHA Class III-IV Diagnosis or suspicion of pure red cell aplasia (PRCA) Planned elective surgery during the study period (except cataract surgery and vascular access surgery) Transfusion of red blood cells during the previous 2 months Pregnant women Any contra-indications to Mircera
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis

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