An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

Completed

• Conditions: Anemia

• Registration Number: NCT01677767
• Lead Sponsor: 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 chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-30
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-03
• Primary Completion: 2013-09-30
• Study Completion: 2013-09-30
• Results First Submitted: 2016-01-06
• Results First Submitted QC: 2016-01-06
• Results First Posted: 2016-02-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Age of Participants Treated With C.E.R.A	Baseline (Week 0)	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	Baseline (Week 0)	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	Up to Week 24	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	Up to Week 24	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	Up to Week 24	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.	Up to Week 24	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

Name	Time	Method
Mean Time Spent by Participants in the Hb Target Range	Up to Week 24	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	Up to Week 24	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.
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study	Up to Week 24	For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
Evaluation of Dose Per Injection of C.E.R.A	Up to Week 24	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	Up to Week 24	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.

Trial Locations

Locations (7)

Sir Gangaram Hospital; 🇮🇳 New Delhi, Delhi, India

Apollo Indraprastha Hospitals; Nephrology; 🇮🇳 New Delhi, India

Aditya Birla Memorial Hospital; 🇮🇳 Pune, India

Vertex Hospital; 🇮🇳 Mumbai, India

Ahmedabad Dialysis Centre; 🇮🇳 Ahmedabad, India

Excel Center; 🇮🇳 Guwahati, India

ESIS Hospital; Department of Nephrology; 🇮🇳 Kolkata, India