A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576602

Purpose

This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. 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: Supportive treatment	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Kidney Transplantation

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 baseline and efficacy evaluation period (EEP). [ Time Frame: Weeks 13-16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
SF36 [ Time Frame: Weeks 16 and 48 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	318
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
2: Active Comparator	Drug: Supportive treatment As prescribed

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;
kidney transplant >=6 months and <5 years prior to randomization;
anemia;
no ESA therapy during 3 months prior to randomization.

Exclusion Criteria:

requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
change in Hb concentration >=1.5g/dL during screening period;
transfusion of red blood cells during 3 months prior to randomization;
poorly controlled hypertension;
significant acute or chronic bleeding within 3 months prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576602

Locations

Belgium

Edegem, Belgium

Gent, Belgium

Leuven, Belgium
France

Amiens, France

Caen, France

Tours, France

Nice, France

Paris, France

Toulouse, France

Le Kremlin-Bicetre, France
Germany

Berlin, Germany

Frankfurt AM Main, Germany

Kaiserslautern, Germany

Kiel, Germany

Munchen, Germany
Italy

Bari, Italy
Spain

Barcelona, Spain

Santander, Spain

Sevilla, Spain
United Kingdom

London, United Kingdom

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:	MH21299
Study First Received:	December 18, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00576602 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics
Hematologic Diseases

Renal Insufficiency, Chronic
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Hematinics
Hematologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses

Hematologic Agents
Kidney Failure, Chronic
Anemia
Kidney Diseases
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on July 02, 2009