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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882713
First Posted: April 16, 2009
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
February 17, 2009
April 16, 2009
July 2, 2016
October 7, 2016
October 7, 2016
February 2009
October 2010   (Final data collection date for primary outcome measure)
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) ]
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.
Proportion of patients maintaining average Hb concentration within target range during Efficacy Evaluation period (EEP) [ Time Frame: Weeks 17-24 ]
Complete list of historical versions of study NCT00882713 on ClinicalTrials.gov Archive Site
  • 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) ]
    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) ]
    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) ]
    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 ]
    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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).
  • Change in hemoglobin concentration between reference (SVP) and the EEP [ Time Frame: Weeks 1-24 ]
  • Proportion of patients maintaining hemoglobin concentration within the hemoglobin range 10.5-12.5g/dL throughout the EEP [ Time Frame: Weeks 17-24 ]
  • Mean time spent in hemoglobin range of 10.5-12.5g/dL [ Time Frame: Every 2 weeks ]
  • Adverse events, laboratory parameters [ Time Frame: At planned visits, to week 48 ]
Not Provided
Not Provided
 
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anemia
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.
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.
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
October 2010
October 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Morocco
 
 
NCT00882713
ML21797
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP