Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients

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.
ClinicalTrials.gov Identifier: NCT00077610
Recruitment Status : Completed
First Posted : February 13, 2004
Results First Posted : February 29, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE February 10, 2004
First Posted Date  ICMJE February 13, 2004
Results First Submitted Date  ICMJE January 29, 2016
Results First Posted Date  ICMJE February 29, 2016
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE February 2004
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period [ Time Frame: Baseline, Week 29 to Week 36 ]
A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00077610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration. [ Time Frame: Baseline, Week 29 to Week 36 ]
    The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.
  • The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods [ Time Frame: Week 1 to Week 36 ]
    The number of participants who received RBC transfusions during the titration and evaluation periods were reported .
  • Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC) [ Time Frame: Up to Week 53 ]
    Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.
  • Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes [ Time Frame: Up to Week 53 ]
    Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L
  • Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 [ Time Frame: Baseline, Week 36 and Week 52 ]
    Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).
  • Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 [ Time Frame: Baseline, Week 36 and Week 52 ]
    Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.
  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death [ Time Frame: Upto Week 53 ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
Official Title  ICMJE A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Brief Summary This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE
  • Drug: Epoetin alfa or beta
    intravenously 3 times weekly for 52 weeks, as prescribed
    Other Name: Epoetin
  • Drug: RO0503821 (1x/2 Weeks)
    60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
    Other Name: Mircera
  • Drug: RO0503821 (1x/4 Weeks)
    120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
    Other Name: Mircera
Study Arms  ICMJE
  • Experimental: RO0503821 (1x/2 Weeks)
    Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
    Intervention: Drug: RO0503821 (1x/2 Weeks)
  • Experimental: RO0503821 (1x/4 Weeks)
    Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
    Intervention: Drug: RO0503821 (1x/4 Weeks)
  • Active Comparator: Epoetin (1-3x/Weeks)
    Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
    Intervention: Drug: Epoetin alfa or beta
Publications * Levin NW, Fishbane S, Cañedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. Erratum in: Lancet. 2008 Feb 2;371(9610):386.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2008)
673
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving IV epoetin for at least 8 weeks before screening.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Italy,   Norway,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00077610
Other Study ID Numbers  ICMJE BA16739
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2016

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