A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00546481
First received: October 18, 2007
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
Drug: Epoetin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented


Secondary Outcome Measures:
  • Mean Change From Baseline in Hemoglobin Concentration at Week 24 [ Time Frame: From Baseline (Day 1) to Week 24 ] [ Designated as safety issue: No ]
    Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value

  • Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.

  • Number of Participants Who Received Red Blood Cells Transfusions up to Week 49 [ Time Frame: Up to Week 49 ] [ Designated as safety issue: No ]
    The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)

  • Number of Participants With Any Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 49 ] [ Designated as safety issue: No ]
    An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.

  • Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 [ Time Frame: From Baseline (Day 1) to Week 24 ] [ Designated as safety issue: No ]
    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit.

  • Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24 [ Time Frame: From Baseline (Day 1) to Week 24 ] [ Designated as safety issue: No ]
    Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1.

  • Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point were reported.


Enrollment: 80
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Correction Phase: CERA Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
0.6 micrograms/kg every 2 weeks
Active Comparator: Correction Phase: Epoetin Beta Drug: Epoetin
As prescribed, iv, 3 times weekly

  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;
  • maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Exclusion Criteria:

  • previous therapy with epoetin within 8 weeks prior to screening;
  • overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
  • RBC transfusions within 8 weeks before screening or during screening period;
  • 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: NCT00546481

Locations
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 431-070
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 134-701
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 405-760
Sungnam, Korea, Republic of, 463-802
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00546481     History of Changes
Other Study ID Numbers: ML20884 
Study First Received: October 18, 2007
Results First Received: April 12, 2016
Last Updated: June 6, 2016
Health Authority: Korea: KFDA

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on July 24, 2016