A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00454246

Purpose

This 2 arm study will assess the efficacy and safety of Mircera in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of s.c. Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly iv Mircera at a starting dose based on their previous s.c. dose, and those in the control group will receive weekly i.v. epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients able to maintain Hb within 10-12g/dL [ Time Frame: 6-7 months post initiation of dialysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dose adjustments [ Time Frame: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end. ] [ Designated as safety issue: No ]
AEs, laboratory parameters, iron parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	2121
Study Start Date:	April 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120-360 micrograms sc monthly starting dose, then iv monthly
2: Active Comparator	Drug: Epoetin alfa or darbepoetin alfa As prescribed, then epoetin iv weekly

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 IV not requiring dialysis;
expected to initiate dialysis within 18 months;
15<=GFR<=29.

Exclusion Criteria:

failing renal allograft in place;
acute or chronic bleeding within 8 weeks prior to screening;
transfusion of red blood cells within 8 weeks prior to screening;
poorly controlled hypertension;
immunosuppressive therapy in the 12 weeks prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454246

Show 78 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:	ML20337
Study First Received:	March 29, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00454246 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epoetin Alfa
Hematinics
Renal Insufficiency, Chronic
Darbepoetin alfa

Anemia
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Therapeutic Uses

Hematologic Agents
Darbepoetin alfa
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009