An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
|ClinicalTrials.gov Identifier: NCT01677767|
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : February 5, 2016
Last Update Posted : July 5, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||127 participants|
|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|
|Actual Study Start Date :||April 30, 2011|
|Primary Completion Date :||September 30, 2013|
|Study Completion Date :||September 30, 2013|
- Mean Age of Participants Treated With C.E.R.A [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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.
- Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study [ Time Frame: 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.
- Mean Time Spent by Participants in the Hb Target Range [ Time Frame: 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 [ Time Frame: 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.
- Evaluation of Dose Per Injection of C.E.R.A [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677767
|Sir Gangaram Hospital|
|New Delhi, Delhi, India, 110060|
|Ahmedabad Dialysis Centre|
|Ahmedabad, India, 380005|
|Guwahati, India, 781007|
|ESIS Hospital; Department of Nephrology|
|Kolkata, India, 600054|
|Mumbai, India, 400083|
|Apollo Indraprastha Hospitals; Nephrology|
|New Delhi, India, 110076|
|Aditya Birla Memorial Hospital|
|Pune, India, 411033|
|Study Director:||Clinical Trials||Hoffmann-La Roche|