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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00605293
First received: January 18, 2008
Last updated: April 8, 2016
Last verified: October 2013
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta
Drug: Epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Hb Concentrations Between Baseline SVP and the EEP [ Time Frame: SVP (Week -4 to -1), EEP (Week 16 to 23) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 101
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605293

Locations
Spain
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00605293     History of Changes
Other Study ID Numbers: ML21060  2007-002065-12 
Study First Received: January 18, 2008
Results First Received: April 8, 2016
Last Updated: April 8, 2016
Health Authority: Spain: Sanitarios

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on May 26, 2016