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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]; Drug: Epoetin

• Registration Number: NCT00546481
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Study Start: 2007-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2016-04-12
• Results First Submitted QC: 2016-06-06
• Results First Posted: 2016-07-18
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Correction Phase: CERA	methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]	-
Correction Phase: Epoetin Beta	Epoetin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Hemoglobin Response up to Week 24	Up to Week 24	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

Name	Time	Method
Mean Change From Baseline in Hemoglobin Concentration at Week 24	From Baseline (Day 1) to Week 24	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	Up to Week 24	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	Up to Week 49	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	Up to Week 49	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	From Baseline (Day 1) to Week 24	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. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24	From Baseline (Day 1) to Week 24	Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24	Up to Week 24	Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.