Clinical trial NCT00642850: STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
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: 2008-03-25
Enrollment: 188
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, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* Chronic renal anemia;
* Continuous stable intravenous maintenance epoetin therapy during previous month;
* Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months;
* Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
* Significant acute or chronic bleeding.

Primary outcomes:
measure: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
timeFrame: Week 17 up to Week 24
Secondary outcomes:
measure: Change in Hemoglobin Concentration Between Reference (SVP) and EEP
timeFrame: Week -4 up to Week -1 and Week 17 up to Week 24
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
timeFrame: Week 17 up to Week 24
measure: Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
timeFrame: Week 17 up to Week 24
measure: Percentage of Participants Requiring Any Dose Adjustment
timeFrame: Week 1 to Week 16 and Week 17 to Week 24
measure: Number of Participants With Red Blood Cell Transfusion During the Study
timeFrame: Week -4 up to Week 28
measure: Number of Participants With Anti-epoetin Antibody
timeFrame: Week -4 and at early withdrawal or Week 28
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Cesky Krumlov
country: Czech Republic
city: Decin
country: Czech Republic
city: Havirov
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Jihlava
country: Czech Republic
city: Karlovy Vary
country: Czech Republic
city: Kolin Iii
country: Czech Republic
city: Liberec
country: Czech Republic
city: Novy Jicin
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Pisek
country: Czech Republic
city: Praha 6
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Strakonice
country: Czech Republic
city: Sumperk
country: Czech Republic
city: Tabor
country: Czech Republic
city: Teplice
country: Czech Republic
city: Trebic
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Znojmo
country: Czech Republic
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.