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A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00882713
First received: February 17, 2009
Last updated: August 12, 2016
Last verified: August 2016
  Purpose
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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 Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period [ Time Frame: EEP (Week 17 to Week 24) ] [ Designated as safety issue: No ]
    The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.


Secondary Outcome Measures:
  • Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period [ Time Frame: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24) ] [ Designated as safety issue: No ]
    Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.

  • Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP [ Time Frame: EEP (Week 17 to Week 24) ] [ Designated as safety issue: No ]
    Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.

  • Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP [ Time Frame: EEP (Week 17 to Week 24) ] [ Designated as safety issue: No ]
    Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.

  • Number of Participants With Any Adverse Events or Serious Adverse Events [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.

  • Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP [ Time Frame: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) ] [ Designated as safety issue: No ]
    Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

  • Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.

  • Mean Hemoglobin Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Hematocrit Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Albumin Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean White Blood Cells and Thrombocytes Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Phosphate and Potassium Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean C-Reactive Protein Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Ferritin Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Transferrin Saturation Levels Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  • Mean Change From Baseline in Pulse Rate Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).

  • Mean Change From Baseline in Blood Pressure Over Time [ Time Frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).

  • Mean Change From Baseline in Weight Over Time [ Time Frame: Week 16 and Week 48 ] [ Designated as safety issue: No ]
    Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).


Enrollment: 202
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C.E.R.A.
Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)
Other Name: C.E.R.A.

  Eligibility

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

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
  • continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).
  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: NCT00882713

Locations
Morocco
Agadir, Morocco, 70000
Casablanca, Morocco, 20000
Casablanca, Morocco, 20100
Casablanca, Morocco, 21000
FÉS, Morocco, 30000
Khouribga, Morocco, 23000
Marrakech, Morocco, 40000
Méknés, Morocco, 50300
Rabat, Morocco, 10150
Rabat, Morocco, 62001
Salé, Morocco, 15045
Tanger, Morocco, 90000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00882713     History of Changes
Other Study ID Numbers: ML21797 
Study First Received: February 17, 2009
Results First Received: July 2, 2016
Last Updated: August 12, 2016
Health Authority: Morocco: Ministry of Public Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on December 05, 2016