- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00550680
A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
February 29, 2016 updated by: Hoffmann-La Roche
A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia.
Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
208
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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Athens, Greece, 11527
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Athens, Greece, 12462
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Athens, Greece, 11528
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Athens, Greece, 11526
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Athens, Greece, 11362
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Athens, Greece, 18454
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Athens, Greece, 18536
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Corinthos, Greece, 20100
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Daphni-athens, Greece, 17237
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Egaleo, Greece, 12244
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Ioannina, Greece, 455 00
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Kalamata, Greece, 24100
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Kyparissia, Greece, 24500
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Lamia, Greece, 35100
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Larissa, Greece, 41 110
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Larissa, Greece, 41221
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Leivadia, Greece, 32100
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Mitilini, Greece, 81100
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Patra, Greece, 26225
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Rhodes, Greece, 85100
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Thessaloniki, Greece, 54629
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Thessaloniki, Greece, 546 42
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Thessaloniki, Greece, 57010
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Thessaloniki, Greece, 57001
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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:
- Adults greater than or equal to (≥) 18 years of age
- Chronic renal anemia
- Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
- Hemodialysis therapy for ≥3 months
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months
- Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
- 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 |
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Experimental: Mircera in Renal Anemia
Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study.
The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment.
Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
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Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection.
Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
Time Frame: Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0).
During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA.
The average Hb during the EEP was calculated per participant and assessed against the reference value.
The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint.
The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
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Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Change in Time-Adjusted Hb From Baseline to EEP
Time Frame: At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0).
During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA.
The average Hb during the EEP was calculated per participant and assessed against the reference value.
The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
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At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
Time Frame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera.
The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined.
The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
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Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Mean Time Spent in the Target Range for Hb During the EEP
Time Frame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA.
Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP.
Time spent in the target range was averaged among all participants and expressed in days.
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Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP
Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24
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Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1.
Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria.
The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.
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Weeks 0, 4, 8, 12, 16, 20, and 24
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Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion
Time Frame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
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The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.
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Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
October 29, 2007
First Submitted That Met QC Criteria
October 29, 2007
First Posted (Estimate)
October 30, 2007
Study Record Updates
Last Update Posted (Estimate)
March 30, 2016
Last Update Submitted That Met QC Criteria
February 29, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20952
- 2006-006349-15 (EudraCT Number)
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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