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

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

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin alfa; Drug: methoxy polyethylene glycol-epoetin beta

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06300
  • Barcelona, Spain, 08035
  • Caceres, Spain, 10310
  • Castellon, Spain, 12004
  • Ciudad Real, Spain, 13005
  • Huelva, Spain, 21005
  • Madrid, Spain, 28034
  • Madrid, Spain, 28905
  • Madrid, Spain, 28041
  • Pontevedra, Spain, 36071
  • Salamanca, Spain, 37008
  • Teruel, Spain, 44003
  • Valencia, Spain, 46010
  • Valencia, Spain, 46009
  • Zamora, Spain, 49022
  • Zaragoza, Spain, 50009
  • Cadiz
    • Cádizv, Cadiz, Spain, 11008
  • Malaga
    • Marbella, Malaga, Spain, 29603
  • Navarra
    • Tudela, Navarra, Spain, 46010

Participation Criteria

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:

• chronic renal anemia;
• continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
• regular hemodialysis for greater than or equal to (>=) 3 months

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months
• poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C.E.R.A; 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 Names: 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; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	EEP (Week 16 to 23)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hb Concentrations Between Baseline SVP and the EEP	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).	SVP (Week -4 to -1), EEP (Week 16 to 23)
Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP	Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.	EEP (Week 16 to 23)
Mean Time Spent in Hb Range 10-12 g/dL		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		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	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).	DTP (Week 0 to 15) up to EEP (Week 16 to 23)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: January 18, 2008
• First Submitted That Met QC Criteria: January 18, 2008
• First Posted (Estimate): January 31, 2008

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: April 8, 2016
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21060; 2007-002065-12 (EudraCT Number)