A Study of Subcutaneous Mircera for the Maintenance Treatment of Pre-Dialysis Patients With Chronic Renal Anemia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00517881

Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for maintenance of hemoglobin levels in pre-dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of Mircera with the starting dose (120, 200 or 360 micrograms) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start. 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

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin beta

U.S. FDA Resources

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 Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Subcutaneous Mircera in Pre-Dialysis Patients With Chronic Renal Anemia

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients maintaining average Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb concentration and percentage of patients maintaining Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Mean time spent in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 or 360 micrograms sc monthly, starting dose

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;
continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months;
acute or chronic bleeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517881

Locations

Sweden

VÄRNAMO, Sweden, 33185

DANDERYD, Sweden, 18288

UMEA, Sweden, 90185

JONKOPING, Sweden, 55185

VÄSTERVIK, Sweden, 59381

UPPSALA, Sweden, 751 85

HUDDINGE, Sweden, 14186

LUND, Sweden, 22185

STOCKHOLM, Sweden, 17176

GOETEBORG, Sweden, 41345

GOTHENBURG, Sweden, S-402 76

TROLLHAETTAN, Sweden, 46185

EKSJO, Sweden, 57581

GAEVLE, Sweden, 80187

ESKILSTUNA, Sweden, 63188

LINKOEPING, Sweden, S-581 85

SKELLEFTEÅ, Sweden, S-931 86

KARLSHAMN, Sweden, S-374 80

BOLLNAS, Sweden, 821 81

KRISTIANSTAD, Sweden, 29185

KARLSTAD, Sweden, 65185

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20944
Study First Received:	August 16, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00517881 History of Changes
Health Authority:	Sweden: Lakemedelsverket (MPA)

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on May 07, 2009