Clinical trial NCT00545571: MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
Official title: A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 120
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 long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[ESA\] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dL\] for Switzerland and 10 to 12 g/dL for Austria).


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
* Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
* Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
* Active malignant disease (except non-melanoma skin cancer)

Primary outcomes:
measure: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)
timeFrame: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
Secondary outcomes:
measure: Mean Change in Time-Adjusted Hb From Baseline to EEP
timeFrame: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
measure: Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)
timeFrame: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
measure: Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP
timeFrame: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
measure: Percentage of Hb Values Above or Below the Target Range During the LTSP
timeFrame: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
measure: Mean Time Spent Above or Below the Target Range for Hb During the LTSP
timeFrame: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
measure: Mean Excursions Above or Below Target Range for Hb During the LTSP
timeFrame: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
measure: Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Mean Dose of Mircera/CERA During the DTP and LTSP
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP
timeFrame: From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Other outcomes:
Locations:
city: Bregenz
country: Austria
city: Feldkirch
country: Austria
city: Graz
country: Austria
city: Kufstein
country: Austria
city: Linz
country: Austria
city: Salzburg
country: Austria
city: St Pölten
country: Austria
city: Steyr
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Basel
country: Switzerland
city: Bellinzona
country: Switzerland
city: Burgdorf
country: Switzerland
city: Geneve
country: Switzerland
city: Lausanne
country: Switzerland
city: Liestal
country: Switzerland
city: Locarno
country: Switzerland
city: Lugano
country: Switzerland
city: Luzern
country: Switzerland
city: Mendrisio
country: Switzerland
city: Sion
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zürich
country: Switzerland
city: Zürich
country: Switzerland
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.