A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00550680
First received: October 29, 2007
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Condition Intervention Phase
Chronic Renal 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, -1,and 0; 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 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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 10.5 to 12.5 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, -1, and 0; 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 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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 17 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 10.5 to 12.5 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 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 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.

  • Percentage of Participants Who Required Any Dose Adjustment 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 17 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 Prematurely Withdrawn From the Study to Receive Blood Transfusion [ 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 were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.


Enrollment: 208
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mircera in Renal Anemia
Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
Drug: Methoxy polyethylene glycol-epoetin beta
Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
Other Name: Mircera/CERA

  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
  • Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
  • Hemodialysis therapy for ≥3 months

Exclusion Criteria:

  • Transfusion of red blood cells during previous 2 months
  • Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
  • 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: NCT00550680

Locations
Greece
Athens, Greece, 11362
Athens, Greece, 11526
Athens, Greece, 11527
Athens, Greece, 11528
Athens, Greece, 12462
Athens, Greece, 18454
Athens, Greece, 18536
Corinthos, Greece, 20100
Daphni-athens, Greece, 17237
Egaleo, Greece, 12244
Ioannina, Greece, 455 00
Kalamata, Greece, 24100
Kyparissia, Greece, 24500
Lamia, Greece, 35100
Larissa, Greece, 41 110
Larissa, Greece, 41221
Leivadia, Greece, 32100
Mitilini, Greece, 81100
Patra, Greece, 26225
Rhodes, Greece, 85100
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 54629
Thessaloniki, Greece, 57001
Thessaloniki, Greece, 57010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00550680     History of Changes
Other Study ID Numbers: ML20952  2006-006349-15 
Study First Received: October 29, 2007
Results First Received: February 29, 2016
Last Updated: February 29, 2016
Health Authority: Greece: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 25, 2016