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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: C.E.R.A.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• India
  • Bhubaneswar, India, 751021
  • Hyderabad, India, 500 029
  • Mumbai, India, 400012
  • Mumbai, India, 400036
  • Vadodara, India, 390005
  • Vellore, India, 632006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Height of Participants at Baseline (Week 0)	The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.	At Baseline (Week 0)
Mean Weight of Participants at Baseline (Week 0)	The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.	At Baseline (Week 0)
Number of Participants With Co-morbidities at Baseline (Week 0)	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.	At Baseline (Week 0)
Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)	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.	Up to Week 24
Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value	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.	Up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study	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.	Up to Week 24
Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)	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.	Up to Week 24
Mean Dose of C.E.R.A. Administered	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.	Up to Week 24
Number of Doses of C.E.R.A. Administered by Different Routes	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.	Up to Week 24
Number of Participants Who Received Concomitant Treatment for Anemia	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.	Up to Week 24
Number of Participants With Adverse Events and Serious Adverse Events	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.	Up to Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: ML25476