A Study of Subcutaneous Mircera For The Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642967

Purpose

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of Mircera, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of ESA previously administered. 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	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Arm, Open Label, French Multi-Centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in Hb concentration [ Time Frame: Between reference and Efficacy Evaluation Period ] [ Designated as safety issue: No ]
Mean time spent in Hb range [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]
% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 16-48 ] [ Designated as safety issue: No ]
AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta s.c. every 4 weeks (starting dose based on previous ESA therapy)

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 kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
continuous stable subcutaneous maintenance ESA therapy during previous month.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
significant acute or chronic bleeding;
poorly controlled hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642967

Contacts

Contact: Please reference Study ID Number: ML21146	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 79 Study Locations

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:	ML21146, 2007-005757-28
Study First Received:	March 19, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00642967 History of Changes
Health Authority:	France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Anemia
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009