Clinical trial NCT00605293: A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
Official title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 101
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 compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.


Eligibility criteria: Inclusion Criteria:

* chronic renal anemia;
* continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
* regular hemodialysis for greater than or equal to (\>=) 3 months

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months
* poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

Primary outcomes:
measure: Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
timeFrame: EEP (Week 16 to 23)
Secondary outcomes:
measure: Change in Hb Concentrations Between Baseline SVP and the EEP
timeFrame: SVP (Week -4 to -1), EEP (Week 16 to 23)
measure: Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP
timeFrame: EEP (Week 16 to 23)
measure: Mean Time Spent in Hb Range 10-12 g/dL
timeFrame: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)
measure: Percentage of Participants Who Required Dose Adjustments During the DTP and EEP
timeFrame: DTP (Week 0 to 15) and EEP (Week 16 to 23)
measure: Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP
timeFrame: DTP (Week 0 to 15) up to EEP (Week 16 to 23)
Other outcomes:
Locations:
city: Cádizv
country: Spain
state: Cadiz
city: Marbella
country: Spain
state: Malaga
city: Tudela
country: Spain
state: Navarra
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: Castellon
country: Spain
city: Ciudad Real
country: Spain
city: Huelva
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Pontevedra
country: Spain
city: Salamanca
country: Spain
city: Teruel
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zamora
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.