A Study of Subcutaneous Mircera 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:	NCT00442702

Purpose

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. 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] Drug: Darbepoetin alfa	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin beta Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study to Compare the Effect of Monthly Subcutaneous Mircera With That of Darbepoetin Alfa, Given According to Local Label, on the Management of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in Hb concentration between baseline and evaluation period [ Time Frame: Months 7-9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hb concentration over time [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
RBC transfusions [ Time Frame: To month 9 ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 and 360 micrograms sc monthly, starting dose
2: Active Comparator	Drug: Darbepoetin alfa As prescribed, sc

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, not requiring dialysis;
receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
active malignant disease;
previous treatment with Mircera.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442702

Contacts

Contact: Please reference Study ID Number: BH20051	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 95 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:	BH20051
Study First Received:	March 1, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00442702 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Darbepoetin alfa
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Hematologic Diseases
Hematinics
Hematologic Agents
Anemia
Kidney Failure, Chronic
Darbepoetin alfa

Pharmacologic Actions
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009