Clinical trial NCT00048035: A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
Official title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 91
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 study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on hemodialysis therapy for at least 3 months;
* receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Primary outcomes:
measure: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
timeFrame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary outcomes:
measure: Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
timeFrame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
measure: Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
timeFrame: Up to Week 126
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 126
measure: Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
timeFrame: From Baseline (Day -28 to Day 1) to Week 126
measure: Mean Change in Pulse Rate
timeFrame: Up to Week 126
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Maywood
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Paterson
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Nashville
country: United States
state: Tennessee
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: