- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677767
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
June 13, 2017 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ahmedabad, India, 380005
- Ahmedabad Dialysis Centre
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Guwahati, India, 781007
- Excel Center
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Kolkata, India, 600054
- ESIS Hospital; Department of Nephrology
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Mumbai, India, 400083
- Vertex Hospital
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New Delhi, India, 110076
- Apollo Indraprastha Hospitals; Nephrology
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Pune, India, 411033
- Aditya Birla Memorial Hospital
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Delhi
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New Delhi, Delhi, India, 110060
- Sir Gangaram Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Age of Participants Treated With C.E.R.A
Time Frame: Baseline (Week 0)
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Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
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Baseline (Week 0)
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Mean Weight of Participants Treated With C.E.R.A
Time Frame: Baseline (Week 0)
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Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
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Baseline (Week 0)
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Number of Participants With Co-morbidity Treated With C.E.R.A
Time Frame: Up to Week 24
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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.
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Up to Week 24
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Mean Time Required to Achieve Target Hemoglobin Range
Time Frame: Up to Week 24
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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
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Up to Week 24
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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.
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Up to Week 24
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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
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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.
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Up to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
Time Frame: Up to Week 24
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For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
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Up to Week 24
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Mean Time Spent by Participants in the Hb Target Range
Time Frame: Up to Week 24
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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.
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Up to Week 24
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Evaluation of Route of Administration for C.E.R.A
Time Frame: Up to Week 24
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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.
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Up to Week 24
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Evaluation of Dose Per Injection of C.E.R.A
Time Frame: Up to Week 24
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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.
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Up to Week 24
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Number of Participants Received Concomitant Medications
Time Frame: Up to Week 24
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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.
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Up to Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2011
Primary Completion (Actual)
September 30, 2013
Study Completion (Actual)
September 30, 2013
Study Registration Dates
First Submitted
August 30, 2012
First Submitted That Met QC Criteria
August 30, 2012
First Posted (Estimate)
September 3, 2012
Study Record Updates
Last Update Posted (Actual)
July 5, 2017
Last Update Submitted That Met QC Criteria
June 13, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25475
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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