- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950819
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (TRANSFORM)
A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, W3400ABH
- Novartis Investigative Site
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Cordoba, Argentina, X5016KEH
- Novartis Investigative Site
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Cordoba, Argentina, X5016KET
- Novartis Investigative Site
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Corrientes, Argentina, W3400
- Novartis Investigative Site
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Santa Fe, Argentina, S3000EPV
- Novartis Investigative Site
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1181ACH
- Novartis Investigative Site
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San Martin, Buenos Aires, Argentina, C1107BEA
- Novartis Investigative Site
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Novartis Investigative Site
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Randwick, New South Wales, Australia, 2031
- Novartis Investigative Site
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Westmead, New South Wales, Australia, 2145
- Novartis Investigative Site
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Novartis Investigative Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- Novartis Investigative Site
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Victoria
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Clayton, Victoria, Australia, 3168
- Novartis Investigative Site
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Heidelberg, Victoria, Australia, 3084
- Novartis Investigative Site
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Parkville, Victoria, Australia, 3050
- Novartis Investigative Site
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Novartis Investigative Site
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Nedlands, Western Australia, Australia, 6009
- Novartis Investigative Site
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Linz, Austria, A-4010
- Novartis Investigative Site
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Novartis Investigative Site
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Bruxelles, Belgium, 1070
- Novartis Investigative Site
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Leuven, Belgium, 3000
- Novartis Investigative Site
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Liege, Belgium, 4000
- Novartis Investigative Site
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Antwerpen
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Edegem, Antwerpen, Belgium, 2650
- Novartis Investigative Site
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RS
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Porto Alegre, RS, Brazil, 90020-090
- Novartis Investigative Site
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SP
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Sao Paulo, SP, Brazil, 05403 000
- Novartis Investigative Site
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São Paulo, SP, Brazil, 04038-002
- Novartis Investigative Site
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BGR
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Sofia, BGR, Bulgaria, 1431
- Novartis Investigative Site
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Santiago, Chile, 8207257
- Novartis Investigative Site
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Bogota, Colombia
- Novartis Investigative Site
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia
- Novartis Investigative Site
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Rijeka, Croatia, 51000
- Novartis Investigative Site
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Zagreb, Croatia, 10000
- Novartis Investigative Site
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Zagreb, Croatia, 1000
- Novartis Investigative Site
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Brno, Czechia, 656 91
- Novartis Investigative Site
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Praha 4, Czechia, 140 00
- Novartis Investigative Site
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Mansoura, Egypt
- Novartis Investigative Site
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Montpellier Cedex 5, France, 34295
- Novartis Investigative Site
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Paris cedex 15, France, 75015
- Novartis Investigative Site
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Reims, France, 51092
- Novartis Investigative Site
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Cedex1
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Nice, Cedex1, France, 06001
- Novartis Investigative Site
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Indre Et Loire
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Tours Cedex 9, Indre Et Loire, France, 37044
- Novartis Investigative Site
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Berlin, Germany, 12203
- Novartis Investigative Site
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Berlin, Germany, 13353
- Novartis Investigative Site
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Essen, Germany, 45147
- Novartis Investigative Site
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Hannover, Germany, 30625
- Novartis Investigative Site
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Hannover Muenden, Germany, 34346
- Novartis Investigative Site
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Heidelberg, Germany, 69120
- Novartis Investigative Site
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Kaiserslautern, Germany, 67655
- Novartis Investigative Site
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Koeln, Germany, 51109
- Novartis Investigative Site
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Leipzig, Germany, 04103
- Novartis Investigative Site
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Muenchen, Germany, 81675
- Novartis Investigative Site
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München, Germany, 81377
- Novartis Investigative Site
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Bavaria
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Regensburg, Bavaria, Germany, 93053
- Novartis Investigative Site
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Athens, Greece, 11527
- Novartis Investigative Site
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Athens, Greece, 106 76
- Novartis Investigative Site
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Patras, Greece, 265 00
- Novartis Investigative Site
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GR
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Thessaloniki, GR, Greece, 546 42
- Novartis Investigative Site
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Delhi
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New Delhi, Delhi, India, 110 017
- Novartis Investigative Site
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Karnataka
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Bangalore, Karnataka, India, 560 055
- Novartis Investigative Site
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Maharashtra
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Mumbai, Maharashtra, India, 400 016
- Novartis Investigative Site
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Tamil Nadu
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Vellore, Tamil Nadu, India, 632004
- Novartis Investigative Site
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Petach Tikva, Israel, 49100
- Novartis Investigative Site
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Tel Aviv, Israel, 64239
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Novara, Italy, 28100
- Novartis Investigative Site
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BA
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Bari, BA, Italy, 70124
- Novartis Investigative Site
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BO
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Bologna, BO, Italy, 40138
- Novartis Investigative Site
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MI
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Milano, MI, Italy, 20162
- Novartis Investigative Site
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PD
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Padova, PD, Italy, 35128
- Novartis Investigative Site
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PR
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Parma, PR, Italy, 43100
- Novartis Investigative Site
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RM
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Roma, RM, Italy, 00168
- Novartis Investigative Site
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Roma, RM, Italy, 00144
- Novartis Investigative Site
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SI
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Siena, SI, Italy, 53100
- Novartis Investigative Site
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TO
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Torino, TO, Italy, 10126
- Novartis Investigative Site
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Aichi
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Nagoya-city, Aichi, Japan, 466-8650
- Novartis Investigative Site
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Toyoake city, Aichi, Japan, 470 1192
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Chiba
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Chiba-city, Chiba, Japan, 260-8712
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Seoul, Korea, Republic of, 03722
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Korea
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Seoul, Korea, Korea, Republic of, 05505
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Seoul, Korea, Korea, Republic of, 06351
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Kuwait, Kuwait
- Novartis Investigative Site
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Ashrafieh, Lebanon, 166830
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Saida, Lebanon, 652
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Saida, Lebanon
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Kuala Lumpur, Malaysia, 50589
- Novartis Investigative Site
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Selangor Darul Ehsan, Malaysia, 68100
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Jalisco
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Guadalajara, Jalisco, Mexico, 44610
- Novartis Investigative Site
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Amsterdam, Netherlands, 1105 AZ
- Novartis Investigative Site
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Groningen, Netherlands
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Leiden, Netherlands, 2333 ZA
- Novartis Investigative Site
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Nijmegen, Netherlands
- Novartis Investigative Site
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AZ
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Maastricht, AZ, Netherlands, 5800
- Novartis Investigative Site
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The Netherlands
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Utrecht, The Netherlands, Netherlands, 3508 GA
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Oslo, Norway, 0424
- Novartis Investigative Site
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Quezon City, Philippines, 1101
- Novartis Investigative Site
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Gdansk, Poland, 80 952
- Novartis Investigative Site
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Poznan, Poland, 60-355
- Novartis Investigative Site
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Poznan, Poland, 60-479
- Novartis Investigative Site
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Pomorskie
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Szczecin, Pomorskie, Poland, 70-111
- Novartis Investigative Site
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Coimbra, Portugal, 3000 075
- Novartis Investigative Site
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Lisboa, Portugal, 1600190
- Novartis Investigative Site
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Lisbon, Portugal, 1069-166
- Novartis Investigative Site
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Porto, Portugal, 4200 319
- Novartis Investigative Site
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Lisboa
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Carnaxide, Lisboa, Portugal, 2790-134
- Novartis Investigative Site
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Ekaterinburg, Russian Federation, 620109
- Novartis Investigative Site
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Krasnodar, Russian Federation, 350086
- Novartis Investigative Site
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Moscow, Russian Federation, 123182
- Novartis Investigative Site
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Moscow, Russian Federation, 129010
- Novartis Investigative Site
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Nizhnii Novgorod, Russian Federation, 603000
- Novartis Investigative Site
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Volzhskiy, Russian Federation, 404120
- Novartis Investigative Site
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Dammam, Saudi Arabia, 15215
- Novartis Investigative Site
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Jeddah, Saudi Arabia, 21499
- Novartis Investigative Site
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Riyadh, Saudi Arabia, 11159
- Novartis Investigative Site
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Belgrade, Serbia, 11000
- Novartis Investigative Site
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Nis, Serbia, 18000
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Novi Sad, Serbia
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Singapore, Singapore, 169608
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Banská Bystrica, Slovakia, 97517
- Novartis Investigative Site
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Bratislava, Slovakia, 833 05
- Novartis Investigative Site
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Kosice, Slovakia, 04166
- Novartis Investigative Site
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Martin, Slovakia, 03659
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Ljubljana, Slovenia, 1000
- Novartis Investigative Site
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Western Province
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Cape Town, Western Province, South Africa, 7925
- Novartis Investigative Site
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Madrid, Spain, 28041
- Novartis Investigative Site
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Madrid, Spain, 28034
- Novartis Investigative Site
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Zaragoza, Spain, 50009
- Novartis Investigative Site
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Andalucia
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Granada, Andalucia, Spain, 18014
- Novartis Investigative Site
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08907
- Novartis Investigative Site
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Cantabria
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Santander, Cantabria, Spain, 39008
- Novartis Investigative Site
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Catalunya
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Barcelona, Catalunya, Spain, 08036
- Novartis Investigative Site
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Barcelona, Catalunya, Spain, 08003
- Novartis Investigative Site
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain, 46017
- Novartis Investigative Site
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Santa Cruz De Tenerife
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La Laguna, Santa Cruz De Tenerife, Spain, 38320
- Novartis Investigative Site
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Göteborg, Sweden, SE-413 45
- Novartis Investigative Site
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Stockholm, Sweden, 14186
- Novartis Investigative Site
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Uppsala, Sweden, 751 85
- Novartis Investigative Site
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Bern, Switzerland, 3010
- Novartis Investigative Site
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Taichung, Taiwan, 40705
- Novartis Investigative Site
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Taipei, Taiwan, 10002
- Novartis Investigative Site
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Taiwan ROC
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Tainan, Taiwan ROC, Taiwan, 70421
- Novartis Investigative Site
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Bangkok, Thailand, 10400
- Novartis Investigative Site
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Bangkok
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Ratchathewi, Bangkok, Thailand, 10400
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Antalya, Turkey, 07070
- Novartis Investigative Site
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Istanbul, Turkey, 34093
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Mecidiyekoy/Istanbul, Turkey, 34394
- Novartis Investigative Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Novartis Investigative Site
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California
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Loma Linda, California, United States, 92354
- Novartis Investigative Site
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Los Angeles, California, United States, 90048
- Novartis Investigative Site
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Los Angeles, California, United States, 90033
- Novartis Investigative Site
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Sacramento, California, United States, 95817-1460
- Novartis Investigative Site
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San Diego, California, United States, 92123
- Novartis Investigative Site
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San Francisco, California, United States, 94115
- Novartis Investigative Site
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San Francisco, California, United States, 94143-0116
- Novartis Investigative Site
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Colorado
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Aurora, Colorado, United States, 80045
- Novartis Investigative Site
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Denver, Colorado, United States, 80210
- Novartis Investigative Site
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Illinois
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Chicago, Illinois, United States, 60612
- Novartis Investigative Site
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Maryland
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Baltimore, Maryland, United States, 21201
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Novartis Investigative Site
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Boston, Massachusetts, United States, 02215
- Novartis Investigative Site
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Burlington, Massachusetts, United States, 01805
- Novartis Investigative Site
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Michigan
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Ann Arbor, Michigan, United States, 48109-0331
- Novartis Investigative Site
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Detroit, Michigan, United States, 48202
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Missouri
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Saint Louis, Missouri, United States, 63110
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New Jersey
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Livingston, New Jersey, United States, 07039
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New York
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Bronx, New York, United States, 10467
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Buffalo, New York, United States, 14215
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Durham, North Carolina, United States, 27710
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Winston-Salem, North Carolina, United States, 27157
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Ohio
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Cleveland, Ohio, United States, 44195
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Cleveland, Ohio, United States, 44106-5048
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Columbus, Ohio, United States, 43210
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17105-8700
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Rhode Island
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Providence, Rhode Island, United States, 02903
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South Carolina
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Charleston, South Carolina, United States, 29425
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Tennessee
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Nashville, Tennessee, United States, 37212-3139
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Texas
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Dallas, Texas, United States, 75246
- Novartis Investigative Site
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77030-2400
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Utah
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Salt Lake City, Utah, United States, 84132
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Virginia
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Charlottesville, Virginia, United States, 22908
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Washington
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Seattle, Washington, United States, 98195
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Milwaukee, Wisconsin, United States, 53226
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent obtained.
- Subject randomized within 24 hr of completion of transplant surgery.
- Recipient of a kidney with a cold ischemia time < 30 hours.
- Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
Exclusion Criteria:
- Subject unable to tolerate oral medication at time of randomization.
- Use of other investigational drugs at the time of enrollment.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Multi-organ transplant recipient.
- Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
- Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.
- Subject who is HIV-positive.
- HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
- Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
- Subject with a BMI greater than 35.
- Subject with severe systemic infections, current or within the two weeks prior to randomization.
- Subject requiring systemic anticoagulation.
- History of malignancy of any organ system.
- Subject with severe restrictive or obstructive pulmonary disorders.
- Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
- Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: EVR+rCNI
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
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All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Other Names:
All subjects received maintenance therapy with corticosteroids throughout the 24 month study period.
A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
Other Names:
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
Other Names:
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ACTIVE_COMPARATOR: MPA+sCNI
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
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All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
Other Names:
All subjects received maintenance therapy with corticosteroids throughout the 24 month study period.
A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
Other Names:
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
Time Frame: Month 12 is Primary, Month 24 secondary
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Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.
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Month 12 is Primary, Month 24 secondary
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
Time Frame: Month 12 and 24
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Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
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Month 12 and 24
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Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
Time Frame: Month 12 and 24
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Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2
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Month 12 and 24
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Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
Time Frame: Month 12 and 24
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Incidence of failure on the composite endpoint of graft loss or death.
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Month 12 and 24
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Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
Time Frame: Month 12 and 24
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Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)
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Month 12 and 24
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Incidence of eGFR < 50 mL/Min/1.73m2
Time Frame: Month 12 and 24
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Incidence of eGFR < 50 mL/min/1.73m2
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Month 12 and 24
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Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
Time Frame: Baseline (week 4), Month 12 and 24
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Renal allograft function : mean estimated glomerular filtration rate, eGFR
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Baseline (week 4), Month 12 and 24
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Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
Time Frame: Month 12 and 24
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Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.
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Month 12 and 24
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Renal Function Assessed by Creatinine Lab Values
Time Frame: Month 12 and 24
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Mean Renal function as assessed in clinical practice, by ceatinine values.
Analysis is done without considering missing values for analysis.
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Month 12 and 24
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Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
Time Frame: Month 12 and 24
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Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g.
CKD-EPI).
Analysis is done without considering missing values for analysis.
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Month 12 and 24
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Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
Time Frame: Month 24
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Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
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Month 24
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Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
Time Frame: Month 24
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Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
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Month 24
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Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
Time Frame: Baseline, Month 12 and 24
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Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.
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Baseline, Month 12 and 24
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Incidence of Major Cardiovascular Events.
Time Frame: Month 24
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Incidence of major cardiovascular events by Preferred Term
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Month 24
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Incidence of Malignancies.
Time Frame: Month 24
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Incidence of malignancies.
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Month 24
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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
Time Frame: Month 12 and 24
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Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2
among compliant subjects.
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Month 12 and 24
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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
Time Frame: Month 12 and 24
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Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:
|
Month 12 and 24
|
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
Time Frame: Month 12 and 24
|
Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:
|
Month 12 and 24
|
Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
Time Frame: Month 12 and 24
|
Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:
|
Month 12 and 24
|
Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
Time Frame: Month 12 and 24
|
Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2
by subgroup
|
Month 12 and 24
|
Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
Time Frame: Month 12 and 24
|
Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2
|
Month 12 and 24
|
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
Time Frame: Month 12 and 24
|
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
|
Month 12 and 24
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.
- Watarai Y, Danguilan R, Casasola C, Chang SS, Ruangkanchanasetr P, Kee T, Wong HS, Kenmochi T, Amante AJ, Shu KH, Ingsathit A, Bernhardt P, Hernandez-Gutierrez MP, Han DJ, Kim MS. Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study. Clin Transplant. 2021 Oct;35(10):e14415. doi: 10.1111/ctr.14415. Epub 2021 Sep 23.
- Citterio F, Henry M, Kim DY, Kim MS, Han DJ, Kenmochi T, Mor E, Tisone G, Bernhardt P, Hernandez Gutierrez MP, Watarai Y. Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study. Expert Opin Drug Saf. 2020 Oct;19(10):1339-1348. doi: 10.1080/14740338.2020.1792441. Epub 2020 Jul 20.
- Berger SP, Sommerer C, Witzke O, Tedesco H, Chadban S, Mulgaonkar S, Qazi Y, de Fijter JW, Oppenheimer F, Cruzado JM, Watarai Y, Massari P, Legendre C, Citterio F, Henry M, Srinivas TR, Vincenti F, Gutierrez MPH, Marti AM, Bernhardt P, Pascual J; TRANSFORM investigators. Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study. Am J Transplant. 2019 Nov;19(11):3018-3034. doi: 10.1111/ajt.15480. Epub 2019 Jul 1.
- Pascual J, Berger SP, Witzke O, Tedesco H, Mulgaonkar S, Qazi Y, Chadban S, Oppenheimer F, Sommerer C, Oberbauer R, Watarai Y, Legendre C, Citterio F, Henry M, Srinivas TR, Luo WL, Marti A, Bernhardt P, Vincenti F; TRANSFORM Investigators. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation. J Am Soc Nephrol. 2018 Jul;29(7):1979-1991. doi: 10.1681/ASN.2018010009. Epub 2018 May 11.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Methylprednisolone
- Prednisone
- Tacrolimus
- Basiliximab
- Thymoglobulin
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- CRAD001A2433
- 2013-000322-66 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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