Clinical trial NCT00364832: A Study of Subcutaneous (sc) Mircera in Dialysis 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 Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis 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: 2006-08-16
Enrollment: 137
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 sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. 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;
* on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
* receiving sc epoetin alfa or beta for at least 3 months 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 preceding 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 or Week 21)
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 or Week 21)
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
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 126
measure: Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
timeFrame: Up to Week 126
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Jose
country: United States
state: California
city: Boston
country: United States
state: Massachusetts
city: Cleveland
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Morgantown
country: United States
state: West Virginia
city: Berlin
country: Germany
city: Mannheim
country: Germany
city: Villingen-schwenningen
country: Germany
city: Wiesloch
country: Germany
city: Bari
country: Italy
city: Bergamo
country: Italy
city: Lecco
country: Italy
city: Lodi
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Vicenza
country: Italy
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Santander
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79. doi: 10.1185/030079907x182103.