- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00661388
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
July 28, 2016 updated by: Hoffmann-La Roche
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients Not Currently Treated With ESA.
This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA).
Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 3
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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Ankara, Turkey, 06100
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Denizli, Turkey, 20100
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Edirne, Turkey, 22030
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Istanbul, Turkey, 34000
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Istanbul, Turkey, 34390
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Istanbul, Turkey, 34377
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Istanbul, Turkey, 34381
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Kahramanmaras, Turkey, 46100
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Konya, Turkey, 42770
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- predialysis stage;
- no ESA therapy during previous 3 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous erythropoietin receptor activator (C.E.R.A.)
Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks.
The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram.
Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.
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sc every month (starting dose 1.2 micrograms/kg)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period
Time Frame: From Baseline (Week 0) to EEP (Week 29 to Week 36)
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Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0).
A positive change from baseline indicates improvement.
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From Baseline (Week 0) to EEP (Week 29 to Week 36)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Time to Achievement of Response During the EEP
Time Frame: From Week 29 to Week 36
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Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders.
Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.
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From Week 29 to Week 36
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The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP
Time Frame: From Week 29 to Week 36
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The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.
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From Week 29 to Week 36
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Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP
Time Frame: From Week 29 to Week 36
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Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.
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From Week 29 to Week 36
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Time Frame: Weeks 0 to Week 36
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Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented.
The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL.
Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
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Weeks 0 to Week 36
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Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
Time Frame: Up to Week 52
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Red blood cell transfusions were given during the treatment period in case of medical need.
Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.
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Up to Week 52
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Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Time Frame: Up to Week 52
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An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation 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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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.
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Up to Week 52
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Mean Change From Baseline in Hb Concentration Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Hematocrit Level Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48
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Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, and 48
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Albumin Concentration Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Creatinine Concentration Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 32, 40
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Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 32, 40
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Mean Change From Baseline in Ferritin Concentration Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean Change From Baseline in Transferrin Saturation Over Time
Time Frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements.
It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
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Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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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
August 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 16, 2008
First Submitted That Met QC Criteria
April 17, 2008
First Posted (Estimate)
April 18, 2008
Study Record Updates
Last Update Posted (Estimate)
August 30, 2016
Last Update Submitted That Met QC Criteria
July 28, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML21524
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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