A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
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|ClinicalTrials.gov Identifier: NCT01156363|
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Procedure: Dialysis Drug: methoxy polyethylene glycol-epoetin beta [Mircera]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
|Experimental: Single Arm||
regular haemodialysis or peritoneal dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
once monthly, subcutaneously or intravenously, for 32 weeks
- Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range [ Time Frame: Weeks 1 to 32 ]Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.
- Mean Monthly Hb Values [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 ]The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
- Change in Hb Concentration Between Reference and Treatment Period [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 ]The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
- Mean Time Participants Spent Having Hb Concentration Within Target Range [ Time Frame: Weeks 1 to 32 ]Target Hb concentration was between 10.0 and 12.0 g/dL.
- Percentage of Participants Requiring Dose Adjustments [ Time Frame: Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8 ]Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156363
|Kaohsiung, Taiwan, 807|
|New Taiepei City, Taiwan|
|Taichung, Taiwan, 404|
|Study Director:||Clinical Trials||Hoffmann-La Roche|