MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

Condition(s) targeted: Anemia

Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

Overall contact:
Please reference Study ID Number: RLI_ML20826, Phone: 973-235-5000

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 patients with chronic renal anemia. Patients currently receiving darbepoetin alfa, epoetin alfa or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120

or 200 micrograms/month (based on the ESA dose administered on week - 1). Subsequent doses

will be adjusted to maintain hemoglobin levels within the country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Official title: A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous Mircera for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia.

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Percentage of patients maintaining average Hb concentration within country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria) OR +/- 1g/dL of reference Hb concentration during evaluation period.

Secondary outcome:

Change in Hb concentration between reference and evaluation period

Mean time spent in country-specific target range; percentage of patients maintaining Hb within target range; dose adjustments; RBC transfusions.

AEs, laboratory parameters, vital signs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- chronic renal anemia;

- Hb conc. in country-specific target range (Switzerland: 11g/dL-13g/dL; Austria:

10g/dL-12g/dL);

- regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;

- continuous iv or sc 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).

Please reference Study ID Number: RLI_ML20826, Phone: 973-235-5000

GRAZ 8020, Austria; Active, not recruiting

WIEN 1160, Austria; Active, not recruiting

WIEN 1100, Austria; Active, not recruiting

WIEN 1030, Austria; Active, not recruiting

WIEN 1220, Austria; Active, not recruiting

KUFSTEIN 6330, Austria; Active, not recruiting

SALZBURG 5020, Austria; Active, not recruiting

STEYR 4400, Austria; Active, not recruiting

LINZ 4020, Austria; Active, not recruiting

ST PÖLTEN 3100, Austria; Active, not recruiting

WIEN 1130, Austria; Active, not recruiting

FELDKIRCH 6807, Austria; Recruiting

BREGENZ 6900, Austria; Active, not recruiting

BASEL 4031, Switzerland; Active, not recruiting

LAUSANNE 1011, Switzerland; Active, not recruiting

BELLINZONA 6500, Switzerland; Active, not recruiting

LOCARNO 6600, Switzerland; Active, not recruiting

MENDRISIO 6850, Switzerland; Active, not recruiting

BURGDORF 3400, Switzerland; Active, not recruiting

LIESTAL 4410, Switzerland; Active, not recruiting

SION 1951, Switzerland; Active, not recruiting

ZÜRICH 8091, Switzerland; Recruiting

GENEVE 1205, Switzerland; Recruiting

ZÜRICH 8037, Switzerland; Active, not recruiting

LUGANO 6903, Switzerland; Active, not recruiting

ST GALLEN 9007, Switzerland; Active, not recruiting

Starting date: October 2007
Ending date: December 2009
Last updated: October 15, 2008