A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576628

Purpose

This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Anemia	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin beta

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in Hb concentration between screening and evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period. [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Recommended starting dose 1.2 micrograms/kg sc monthly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
chronic renal anemia, with no need for dialysis expected in next 3 months;
adequate iron status.

Exclusion Criteria:

previous epoetin therapy within 12 weeks prior to treatment;
transfusion of red blood cells during 2 months prior to screening;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
hemolysis;
folic acid and vitamin B 12 deficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576628

Locations

Russian Federation

ROSTOV-NA-DONU, Russian Federation, 344029

ST PETERSBURG, Russian Federation, 195067

NIZHNY NOVGOROD, Russian Federation, 603001

MOSCOW, Russian Federation, 129110

OMSK, Russian Federation, 644112

SARATOV, Russian Federation, 410053

IRKUTSK, Russian Federation, 664079

TJUMEN, Russian Federation, 625023

ORENBURG, Russian Federation, 460018

EKATERINBURG, Russian Federation, 620102

ST PETERSBURG, Russian Federation, 197110

NIZHNY NOVGOROD, Russian Federation, 603126

MOSCOW, Russian Federation, 117036

MOSCOW, Russian Federation, 125315

ST PETERSBURG, Russian Federation, 194354

MOSCOW, Russian Federation, 125101

MOSCOW, Russian Federation, 123182

KHANTY-MANSIYSK, Russian Federation, 628011

ST PETERSBURG, Russian Federation, 197089

KHABAROVSK, Russian Federation, 680009

UFA, Russian Federation, 450005

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	ML20978
Study First Received:	December 18, 2007
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00576628 History of Changes
Health Authority:	Russia: Federal Agency of Drug Quality Control

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on November 05, 2009