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

Sponsors

Lead Sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
Brief Summary

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.

Overall Status Completed
Start Date August 2011
Completion Date November 2013
Primary Completion Date November 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Mean Height of Participants at Baseline (Week 0) At Baseline (Week 0)
Mean Weight of Participants at Baseline (Week 0) At Baseline (Week 0)
Number of Participants With Co-morbidities at Baseline (Week 0) At Baseline (Week 0)
Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter) Up to Week 24
Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value Up to Week 24
Secondary Outcome
Measure Time Frame
Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study Up to Week 24
Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter) Up to Week 24
Mean Dose of C.E.R.A. Administered Up to Week 24
Number of Doses of C.E.R.A. Administered by Different Routes Up to Week 24
Number of Participants Who Received Concomitant Treatment for Anemia Up to Week 24
Number of Participants With Adverse Events and Serious Adverse Events Up to Week 24
Enrollment 108
Condition
Intervention

Intervention Type: Drug

Intervention Name: C.E.R.A.

Description: 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.

Arm Group Label: C.E.R.A.

Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
Facility:
| Bhubaneswar, 751021, India
| Hyderabad, 500 029, India
| Mumbai, 400012, India
| Mumbai, 400036, India
| Vadodara, 390005, India
| Vellore, 632006, India
Location Countries

India

Verification Date

April 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: C.E.R.A.

Description: 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.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov