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

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

MedlinePlus related topics:

Anemia Kidney Transplantation

ChemIDplus related topics:

Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

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.

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

Contacts


Contact: Please reference Study ID Number: PDO_MH21299	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Locations


Belgium
		Recruiting
	LEUVEN, Belgium, 3000
		Recruiting
	GENT, Belgium, 9000
		Recruiting
	EDEGEM, Belgium, 2650

France
		Recruiting
	TOULOUSE, France, 31054
		Recruiting
	PARIS, France, 75475
		Recruiting
	AMIENS, France, 80054
		Recruiting
	TOURS, France, 37044
		Recruiting
	NICE, France, 06002
		Recruiting
	LE KREMLIN-BICETRE, France, 94275
		Recruiting
	CAEN, France, 14033

Germany
		Recruiting
	BERLIN, Germany, 13353
		Recruiting
	KAISERSLAUTERN, Germany, 67655
		Recruiting
	KIEL, Germany, 24105
		Recruiting
	MÜNCHEN, Germany, 80336
		Not yet recruiting
	BONN, Germany, 53127

Italy
		Recruiting
	BARI, Italy, 70124

Poland
		Not yet recruiting
	GDANSK, Poland, 80-211
		Not yet recruiting
	SZCZECIN, Poland, 70-111
		Not yet recruiting
	WROCLAW, Poland, 50-417
		Not yet recruiting
	WARSZAWA, Poland, 02-006
		Not yet recruiting
	POZNAN, Poland, 60-479

Spain
		Recruiting
	BARCELONA, Spain, 08036
		Recruiting
	SEVILLA, Spain, 41013

United Kingdom
		Recruiting
	LONDON, United Kingdom, SE22 8PT
		Not yet recruiting
	NOTTINGHAM, United Kingdom, NG5 1PB

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MH21299
First Received:	December 18, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00576602
Health Authority:	France:Agence francaise de Securite Sanitaria des Products de Sante (AFSSAPS)

Study placed in the following topic categories:

Epoetin Alfa

Renal Insufficiency

Urologic Diseases

Renal Insufficiency, Chronic

Hematologic Diseases

Anemia

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

ClinicalTrials.gov processed this record on September 05, 2008

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