Clinical trial NCT00660023: A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis 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: 2008-04-17
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
* Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Poorly controlled hypertension
* Significant acute or chronic bleeding

Primary outcomes:
measure: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
timeFrame: Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Secondary outcomes:
measure: Mean Change in Time-Adjusted Hb From Baseline to EEP
timeFrame: At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
measure: Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
timeFrame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
measure: Mean Time Spent in the Target Range for Hb During the EEP
timeFrame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
measure: Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Number of Participants Receiving Blood Transfusion During the DTP and EEP
timeFrame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
measure: Number of Blood Transfusions During the DTP and EEP
timeFrame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
Other outcomes:
Locations:
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Esztergom
country: Hungary
city: Keszthely
country: Hungary
city: Miskolc
country: Hungary
city: Salgótarján
country: Hungary
city: Szolnok
country: Hungary
city: VAC
country: Hungary
city: Zalaegerszeg
country: Hungary
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.