Clinical trial NCT00550680: A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
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: Chronic Renal Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 208
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 intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
* Hemodialysis therapy for ≥3 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
* 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, -1,and 0; 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, -1, and 0; 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: Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion
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: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Corinthos
country: Greece
city: Daphni-athens
country: Greece
city: Egaleo
country: Greece
city: Ioannina
country: Greece
city: Kalamata
country: Greece
city: Kyparissia
country: Greece
city: Lamia
country: Greece
city: Larissa
country: Greece
city: Larissa
country: Greece
city: Leivadia
country: Greece
city: Mitilini
country: Greece
city: Patra
country: Greece
city: Rhodes
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
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.