Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01695746
First received: September 27, 2012
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Condition Intervention
Anemia
Drug: C.E.R.A.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Methoxy Poly-Ethylene Glycol Epoetin Beta (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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Height of Participants at Baseline (Week 0) [ Time Frame: At Baseline (Week 0) ] [ Designated as safety issue: No ]
    The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.

  • Mean Weight of Participants at Baseline (Week 0) [ Time Frame: At Baseline (Week 0) ] [ Designated as safety issue: No ]
    The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.

  • Number of Participants With Co-morbidities at Baseline (Week 0) [ Time Frame: At Baseline (Week 0) ] [ Designated as safety issue: No ]
    Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.

  • Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter) [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.

  • Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.

  • Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter) [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.

  • Mean Dose of C.E.R.A. Administered [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.

  • Number of Doses of C.E.R.A. Administered by Different Routes [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.

  • Number of Participants Who Received Concomitant Treatment for Anemia [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.

  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.


Enrollment: 108
Study Start Date: August 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
C.E.R.A.
Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
Drug: C.E.R.A.
Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with stage III-IV chronic kidney disease not on dialysis receiving treatment with Mircera for chronic renal anemia
Criteria

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age, inclusive
  • Patients with stage III-IV chronic kidney disease not on dialysis
  • Erythropoiesis stimulating agent (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 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
  • 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: NCT01695746

Locations
India
Bhubaneswar, India, 751021
Hyderabad, India, 500 029
Mumbai, India, 400012
Mumbai, India, 400036
Vadodara, India, 390005
Vellore, India, 632006
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01695746     History of Changes
Other Study ID Numbers: ML25476 
Study First Received: September 27, 2012
Results First Received: March 8, 2016
Last Updated: April 26, 2016
Health Authority: India: Drug Controller General

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on December 02, 2016