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
  Purpose
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
Anemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 127
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677767

Locations
India
Ahmedabad, India, 380005
Guwahati, India, 781007
Kolkata, India, 600054
Mumbai, India, 400083
New Delhi, India, 110060
New Delhi, India, 110076
Pune, India, 411033
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01677767     History of Changes
Other Study ID Numbers: ML25475 
Study First Received: August 30, 2012
Results First Received: January 6, 2016
Last Updated: February 8, 2016
Health Authority: India: Drug Controller General

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 02, 2016