A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
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|ClinicalTrials.gov Identifier: NCT00605293|
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : May 13, 2016
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: methoxy polyethylene glycol-epoetin beta Drug: Epoetin alfa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
Drug: methoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms iv/month (starting dose)
Other Name: Mircera; C.E.R.A
Active Comparator: Epoetin Alfa
Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
Drug: Epoetin alfa
- Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP [ Time Frame: EEP (Week 16 to 23) ]Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.
- Change in Hb Concentrations Between Baseline SVP and the EEP [ Time Frame: SVP (Week -4 to -1), EEP (Week 16 to 23) ]Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).
- Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP [ Time Frame: EEP (Week 16 to 23) ]Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.
- Mean Time Spent in Hb Range 10-12 g/dL [ Time Frame: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23) ]
- Percentage of Participants Who Required Dose Adjustments During the DTP and EEP [ Time Frame: DTP (Week 0 to 15) and EEP (Week 16 to 23) ]
- Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP [ Time Frame: DTP (Week 0 to 15) up to EEP (Week 16 to 23) ]RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).
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): NCT00605293
|Cádizv, Cadiz, Spain, 11008|
|Marbella, Malaga, Spain, 29603|
|Tudela, Navarra, Spain, 46010|
|Badajoz, Spain, 06300|
|Barcelona, Spain, 08035|
|Caceres, Spain, 10310|
|Castellon, Spain, 12004|
|Ciudad Real, Spain, 13005|
|Huelva, Spain, 21005|
|Madrid, Spain, 28034|
|Madrid, Spain, 28041|
|Madrid, Spain, 28905|
|Pontevedra, Spain, 36071|
|Salamanca, Spain, 37008|
|Teruel, Spain, 44003|
|Valencia, Spain, 46009|
|Valencia, Spain, 46010|
|Zamora, Spain, 49022|
|Zaragoza, Spain, 50009|
|Study Director:||Clinical Trials||Hoffmann-La Roche|