Study Details

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Phase 3b study to evaluate Advagraf in combination with mycophenolate mofetil and basiliximab in liver transplantation

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01011205

Astellas Study ID

The unique identification code given by the study sponsor.

PMR-EC-1106

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2010-021075-89

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Condition

Liver Transplants

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Sep 2009 - Jan 2013

Masking

None (Open Label)

Enrollment number

893

A multicenter, three arm, randomized, open label clinical study to compare renal function in liver transplant recipients receiving an immunosuppressive regimen of Advagraf (immediately or delayed post-transplant) and MMF with or without a Monoclonal Anti-IL2R antibody (Basiliximab)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Would you like more information about clinical trial sites that are recruiting participants for Phase 3b study to evaluate Advagraf in combination with mycophenolate mofetil and basiliximab in liver transplantation? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

073

Bergamo, Italy, 24122

008

Brussels, Belgium, 1070

106

Barcelona, Spain, 08907

061

Budapest, Hungary, 1082

035

Paris, France, 92118

107

El Palmar, Spain, 30120

148

Johannesburg, South Africa

111

Santiago de Compostela, Spain, 15706

077

Naples, Italy, 80131

076

Genova, Italy, 16132

010

Liege, Belgium, 4000

142

Jena, Germany, 07747

147

Prague, Czech Republic, 14021

037

Nice, France, 06202

117

Madrid, Spain, 28222

034

Villejuif, France, 94804

021

Copenhagen, Denmark, 2100

052

Munster, Germany, 48149

Site: 166

Mexico City, Mexico

138

London, United Kingdom, SE5 9RS

127

Uppsala, Sweden, 75185

126

Gothenberg, Sweden, 41345

007

Antwerp, Belgium, 2650

087

Warsaw, Poland, 2006

098

St. Petersburg, Russian Federation, 197758

040

Paris, France, 75679

158

Montpelier, France, 34295

116

Zaragoza, Spain, 50009

167

Salvador, Mexico

Site: 156

Mainz, Germany

153

Edmonton, Canada, T6G2XB

033

Toulouse, France, 31054

136

Birmingham, United Kingdom, Bi5 2TH

169

Bogata, Colombia

042

Paris, France, 75571

110

Barcelona, Spain, 8035

032

Lyon, France, 69437

045

Marseille, France, 13385

009

Leuven, Belgium, 3000

043

Caen, France, 14033

051

Frankfurt, Germany, 60559

006

Gent, Belgium, 9000

058

Erlangen, Germany, 91054

001

Innsbruck, Austria, 6020

055

Gottingen, Germany, 37099

059

Tubingen, Germany, 72076

075

Bologna, Italy, 40138

039

Lyon, France, 69317

056

Berlin, Germany, 13353

171

Leeds, United Kingdom, LS9 7TF

044

Paris, France, 75651

036

Rennes, France, 35033

160

Buenos Aires, Argentina

157

Bordeaux, France, 33076

150

Halifax, Canada, B3H2Y9

112

Malaga, Spain, 29010

054

Leipzig, Germany, 4103

086

Warsaw, Poland, 02-097

108

Madrid, Spain, 28041

031

Creteil, France, 94000

141

Munich, Germany, 81377

131

Zurich, Switzerland, 8091

151

London, Canada, N6A5A5

114

A Coruna, Spain, 15006

113

Sevilla, Spain, 41013

060

Regensberg, Germany, 93042

163

Sao Paulo, Brazil

115

Madrid, Spain, 28034

109

Barcelona, Spain, 08036

053

Kiel, Germany, 24105

154

Vancouver, Canada, N5Z3X7

096

Moscow, Russian Federation, 123182

072

Padova, Italy, 35127

038

Strasbourg, France, 67098

041

Besancon, France, 25030

152

Montreal, Canada, H2X3J4

078

Palermo, Italy, 90134

026

Helsinki, Finland, 130

143

Mainz, Germany, 156

070

Dublin, Ireland, 4

081

Oslo, Norway, 27

091

Bucharest, Romania, 22328

057

Hannover, Germany, 30625

146

Minsk, Belarus, 220116

097

Moscow, Russian Federation, 129090

074

Rome, Italy, 144

137

London, United Kingdom, NW3 2QG

079

Naples, Italy, 80131

071

Udine, Italy, 33100

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