Clinical trial NCT00546481: A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
timeFrame: Up to Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Hemoglobin Concentration at Week 24
timeFrame: From Baseline (Day 1) to Week 24
measure: Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24
timeFrame: Up to Week 24
measure: Number of Participants Who Received Red Blood Cells Transfusions up to Week 49
timeFrame: Up to Week 49
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to Week 49
measure: Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24
timeFrame: From Baseline (Day 1) to Week 24
measure: Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24
timeFrame: From Baseline (Day 1) to Week 24
measure: Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Sungnam
country: Korea, Republic of
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, Chung W, Kim S, Huh W, Oh HY, Choi BS, Yang CW, Kim S. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis. J Korean Med Sci. 2014 Jan;29(1):76-83. doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26.