A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00660023
First received: April 16, 2008
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

Condition Intervention Phase
Anemia
Drug: Methoxy polyethylene glycol-epoetin beta
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 ] [ Designated as safety issue: No ]
    Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. 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 10.0 to 12.0 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.


Secondary Outcome Measures:
  • Mean Change in Time-Adjusted Hb From Baseline to EEP [ Time Frame: At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24 ] [ Designated as safety issue: No ]
    Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. 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.

  • 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 ] [ Designated as safety issue: No ]
    During the EEP (Weeks 18 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 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.

  • 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 ] [ Designated as safety issue: No ]
    During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 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.

  • Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    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 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.

  • Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    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 18 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.

  • Number of Participants Receiving Blood Transfusion During the DTP and EEP [ Time Frame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 ] [ Designated as safety issue: No ]
    The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.

  • Number of Blood Transfusions During the DTP and EEP [ Time Frame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24 ] [ Designated as safety issue: No ]
    The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.


Enrollment: 124
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mircera in Renal Anemia
Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
Drug: Methoxy polyethylene glycol-epoetin beta
Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
Other Name: CERA/Mircera

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults greater than or equal to (≥) 18 years of age
  • Chronic renal anemia
  • Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
  • Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion Criteria:

  • Transfusion of red blood cells during previous 2 months
  • Poorly controlled hypertension
  • Significant acute or chronic bleeding
  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: NCT00660023

Locations
Hungary
Baja, Hungary, 6500
Budapest, Hungary, 1062
Debrecen, Hungary, 4032
Esztergom, Hungary, 2500
Keszthely, Hungary, 8360
Miskolc, Hungary, 3526
Salgótarján, Hungary, 3100
Szolnok, Hungary, 5000
VAC, Hungary, 2600
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00660023     History of Changes
Other Study ID Numbers: ML20752  2006-005621-28 
Study First Received: April 16, 2008
Results First Received: February 16, 2016
Last Updated: February 16, 2016
Health Authority: Hungary: National Institute of Pharmacy, Central Ethics Committee

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 21, 2016