Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (TEMPO3:4)
30 de mayo de 2017 actualizado por: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other important consequences of ADPKD.
During the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and 90/30 mg orally upon awakening and approximately 9 hours later. As soon as a subject could not tolerate a given dose, the titration phase was over and the maintenance phase began at the dose level tolerated. The maintenance phase lasted to Month 36. Subjects were able to titrate down at any point during the study. Subjects were able to titrate up during the maintenance phase with Medical Monitor approval.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1445
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Dresden, Alemania, 1307
- Universitätsklinikum Carl Gustav Carus
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Düsseldorf, Alemania, 40210
- Nephrologische Gemeinschaftspraxis/Dialysezentrum
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Essen, Alemania, 45147
- Klinik für Nieren- und Hochdruckkrankheiten
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Freiburg, Alemania, 78106
- Universitätsklinikum Freiburg
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Heidelberg, Alemania, 69120
- Universitätskliniken Heidelberg
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Nuernberg, Alemania, 90471
- UH Erlangen/Nürnberg
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Buenos Aires, Argentina, 1425
- Instituto de Nefrología, Nefrology SA
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Buenos Aires, Argentina, 1602
- Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay
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Buenos Aires, Argentina, B1664INZ
- Hosptial Universitario Austral
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Cordoba, Argentina, X5000IUP
- Sanatorio Allende
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Cordoba, Argentina, X5016KEA
- Hospital Privado-Centro Medico de Cordoba
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Adelaide, Australia, 5000
- Royal Adelaide Hospital
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Adelaide, Australia, 5011
- Queen Elizebeth Hospital
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Brisbane, Australia, 4102
- Princess Alexandra Hospital
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Melbourne, Australia, 3050
- Royal Melbourne Hospital
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Melbourne, Australia, 3121
- Melbourne Renal Research Group
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Perth, Australia, 6054
- Royal Perth Hospital
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Sydney, Australia, 2065
- Royal North Shore Hospital
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Sydney, Australia, 2145
- Westmead Hospital
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Brussel, Bélgica, 1090
- UZ Brussel
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Brussels, Bélgica, 1200
- UCL-St Luc
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Gent, Bélgica, 9000
- UZ Gent
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H1v8
- Queen Elizabeth II Health Science Center, Division of Nephrology
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Quebec
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Montreal, Quebec, Canadá, H3A1A1
- Royal Victoria Hospital
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Montreal, Quebec, Canadá, H4J1C5
- Hospital du Sacre- Coeur de Montreal
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Herlev, Dinamarca, 2730
- Herlev Amtssygehus
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Odense, Dinamarca, 5000
- Odense Universitetshospital
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Alabama
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Mobile, Alabama, Estados Unidos, 36617
- University of South Alabama
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Mobile, Alabama, Estados Unidos, 36608
- Coastal Clinical Research
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California
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Riverside, California, Estados Unidos, 92503
- Apex Research of Riverside
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Stanford, California, Estados Unidos, 94305-5114
- Stanford University Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale University School of Medicine
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Florida
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Jacksonville, Florida, Estados Unidos, 32216
- Jacksonville Center for Clinical Research
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Port Charlotte, Florida, Estados Unidos, 33952
- Coastal Nephrology Associates Research Center, LLC
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University School of Medicine
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Renal Associates of Baton Rough, L.L.C.
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- John Hopkins School of Medicine
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts- New England Medical Center
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Medical Center
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New York
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Buffalo, New York, Estados Unidos, 14215
- Erie County Medical Center
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Hawthorne, New York, Estados Unidos, 10532
- Nephrology Associates of Westchester
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10021
- The Rogosin Institute
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina, UNC, Kidney Center
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Greenville, North Carolina, Estados Unidos, 27834
- East Carolina University
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45220
- Kidney and Hypertension Center
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals of Cleveland/Case
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- Northwest Renal Clinic, Inc.
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Medical Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29405
- Charleston Nephrology Associates
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37205
- Nephrology Associates, P.C.
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Nashville, Tennessee, Estados Unidos, 37232-1371
- Vanderbilt University Medical Center
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia, Nephrology Clinical Research Center
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Kemerovo, Federación Rusa, 650061
- Kemerovo Medical Academy, Regional Clinical Hospital
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Moscow, Federación Rusa, 123060
- City Clinical Hospital #52
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St. Petersburg, Federación Rusa, 191104
- City Mariinskiy Hospital
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St.-Petersburg, Federación Rusa, 194291
- Leningrad Regional Clinical Hospital
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Tomsk, Federación Rusa, 634063
- Tomsk Regional Clinical Hospital
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Bordeaux, Francia, 33076
- CHU-Hopital Pellegrin
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Caen Cedex, Francia, 14033
- CHU - Hôpital Clémenceau
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Lyon Cedex 3, Francia, 69437
- Hôpital Edouard Herriot
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Marseille, Francia, 13005
- Hôpital de la Conception
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Montpellier, Francia, 34295
- CHU - Hôpital Lapeyronie
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Paris, Francia, 75018
- Hopital Bichat-Claude Bernard
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Reims cedex, Francia, 51092
- Centre Hospitalier Universitaire
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Saint-Etienne Cedex 2, Francia, 42055
- CHU - Hôpital Nord
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Toulouse Cedex 09, Francia, 31059
- Hopital Rangueil
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Bergamo, Italia, 24128
- Ospedali Riuniti di Bergamo
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Milano, Italia, 20132
- Università Vita e Salute, Ospedale San Raffaele
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Modena, Italia, 41100
- Policlinico di Modena
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Napoli, Italia, 80131
- Policlinico
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Pavia, Italia, 27100
- IRCCS Fondazione Salvatore Maugeri
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Chiba, Japón, 2608677
- Chiba University Hospital
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Chiba, Japón, 2608712
- National Hospital Organization Chiba-East Hospital
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Fukuoka, Japón, 8128582
- Kyusyu University Hospital
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Fukushima, Japón, 9601295
- Fukushima Medical University Hospital
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Hiroshima, Japón, 7348551
- Hiroshima University Hospital
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Kumamoto, Japón, 8608556
- Kumamoto Univeristy Hospital
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Kyoto, Japón, 6068507
- Kyoto University Hospital
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Kyoto, Japón, 612-8555
- National Hospital Organization Kyoto Medical Center
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Niigata, Japón, 9518520
- Niigata University Medical & Dental Hospital
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Osaka, Japón, 5500015
- Ohno Memorial Hospital
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Saitama, Japón, 3308503
- Saitama Medical Center Jichi Medical University
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Aichi
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Toyoake, Aichi, Japón, 4701192
- Fujita Health University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japón, 608648
- Hokkaido University Hospital
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Kanagawa
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Isehara, Kanagawa, Japón, 2591193
- Tokai University Hospital
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Kawasaki, Kanagawa, Japón, 2138587
- Toranomon Hospital Kajigaya
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Sagamihara, Kanagawa, Japón, 2288555
- Kitasato University Hospital
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Miyagi
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Sendai, Miyagi, Japón, 9808574
- Tohoku University Hospital
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Osaka
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Osaka-City, Osaka, Japón, 5458586
- Osaka City University Hospital
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Suita, Osaka, Japón, 5650871
- Osaka University Hospital
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Saitama
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Kasukabe, Saitama, Japón, 3440035
- Shuwa General Hospital
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Kawagoe, Saitama, Japón, 3508500
- Saitama Medical Center
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Shizuoka
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Hamamatsu, Shizuoka, Japón, 4313192
- Hamamatsu University School of Medicine, University Hospital
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Tochigi
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Shimotsuke, Tochigi, Japón, 3290498
- Jichi Medical School Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japón, 1138603
- Nippon Medical School Hospital
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Bunkyo-ku, Tokyo, Japón, 1138519
- Tokyo Medical & Dental University Hospital, Faculty of Medicine
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Itabashi-ku, Tokyo, Japón, 1738606
- Teikyo University Hospital
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Minato-Ku, Tokyo, Japón, 1058471
- The Jikei University Hospital
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Minato-ku, Tokyo, Japón, 1058470
- Toranomon Hospital
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Mitaka, Tokyo, Japón, 1818611
- Kyorin University Hospital
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Shinjuku-ku, Tokyo, Japón, 1628666
- Tokyo Women's Medical University Hospital
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Amsterdam, Países Bajos, 1081 HV
- VU Medisch Centrum
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Groningen, Países Bajos, 9713 GZ
- UMCG Groningen
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Ciechanow, Polonia, 06-400
- Oddział Nefrologiczny Stacja Dializ
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Gdansk, Polonia, 80-952
- Akademickie Centrum Kliniczne AMG
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Gdansk, Polonia, 80-952
- Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG
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Krakow, Polonia, 31-501
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie
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Lodz, Polonia, 90-153
- SOP ZOZ Uniwersytecki Szpital Kliniczny
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Lublin, Polonia, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
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Warsaw, Polonia, 04-749
- Miedzyleski Szpital Specjalistyczny w Warszawie
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Warsaw, Polonia, 02-507
- Klinika Chorób Wewnętrznych i Nefrologii
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Warszawa, Polonia, 03-401
- Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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Warszawa, Polonia, 03-401
- Szpital Praski, Samodzielny Publiczny ZOZ
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Wroclaw, Polonia, 50-417
- Akademicki Szpital Kliniczny im J Mikulicza Radeckiego
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Belfast, Reino Unido, BT9 7AB
- Belfast City Hospital
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Birmingham, Reino Unido, B15 2TH
- Oueen Elizabeth Hospital
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Brighton, Reino Unido, BN2 5BE
- Sussex Renal Unit Royal Sussex County Hospital
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Coventry, Reino Unido, CV2 2DX
- Uhcw Mhs Trust
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Edinburgh, Reino Unido, EH16 4SA
- Royal Infirmary
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Inverness, Reino Unido, IV2 3UJ
- Raigmore Hospital
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London, Reino Unido, NW3 2PF
- Royal Free and University College Medical School
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London, Reino Unido, SE5-9RS
- King's College Hospital
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London, Reino Unido, SW170RE
- St. George's Hospital
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Sheffield, Reino Unido, S5 7AU
- Royal Hallamshire Hospital
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Swansea, Reino Unido, SA6 6NL
- Morriston Hospital
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Bucharest, Rumania, 22328
- Institutul Clinic Fundeni
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Bucharest, Rumania, 10731
- Spitalul Clinic de Nefrologie Dr. Carol Davila
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Iasi, Rumania, 700503
- Spitalul Clinic "C.I.Parhon"
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Legal adult age and able to give Informed Consent.
- Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.
- Willingness to comply with reproductive precautions, if female.
- Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.
- Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (MRI) at randomization.
Exclusion Criteria:
- Prior exposure to tolvaptan or other experimental PKD therapies.
- Currently taking medication for purpose of affecting PKD cysts.
- Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
- In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives.
- Patients who are unlikely to adequately comply with study procedures.
- Patients having contraindications to MRI.
- Patients taking medications or having any illnesses likely to affect ADPKD outcomes.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Tolvaptan
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
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Tolvaptan was supplied as tablets.
Otros nombres:
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Comparador de placebos: Placebo
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
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Placebo was supplied as tablets.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
Periodo de tiempo: Baseline to Month 36
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Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility.
At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.
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Baseline to Month 36
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36
Periodo de tiempo: Baseline to Month 36
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These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis.
Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD.
The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have > 139 mmHg systolic blood pressure [BP], > 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline.
Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol).
Categories included normal (< 2.8 female or < 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (> 28 female or > 20 male.
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Baseline to Month 36
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Change in Renal Function Per Year From Week 3 to Month 36
Periodo de tiempo: Week 3 to Month 36
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Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine.
The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL).
The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.
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Week 3 to Month 36
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Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36
Periodo de tiempo: Baseline to Month 36
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For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason.
The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.
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Baseline to Month 36
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Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36
Periodo de tiempo: At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2
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Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives [eg, tricyclic antidepressants]) or surgical therapy for pain.
In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain.
A negative change score indicates less pain.
AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.
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At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2
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Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36
Periodo de tiempo: Baseline to Month 36
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A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP [sBP] > 129 mmHg and/or diastolic BP [dBP] > 84 mmHg), (2) hypertensive (sBP > 139 mmHg and/or dBP > 89 mmHg), or (3) requiring antihypertensive therapy.
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Baseline to Month 36
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Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36
Periodo de tiempo: Baseline to Month 36
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Baseline to Month 36
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Vicente Torres, MD, PhD, Mayo Medical Center
- Director de estudio: Frank Czerwiec, MD, PhD, Otsuka Pharmaceutical Development and Commercialization, Inc.
- Director de estudio: Osamu Sato, Otsuka Pharmaceutical Corporation, Ltd. Japan
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.
- Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.
- Gattone VH 2nd, Wang X, Harris PC, Torres VE. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nat Med. 2003 Oct;9(10):1323-6. doi: 10.1038/nm935. Epub 2003 Sep 21.
- Torres VE, Wang X, Qian Q, Somlo S, Harris PC, Gattone VH 2nd. Effective treatment of an orthologous model of autosomal dominant polycystic kidney disease. Nat Med. 2004 Apr;10(4):363-4. doi: 10.1038/nm1004. Epub 2004 Feb 29.
- Watkins PB, Lewis JH, Kaplowitz N, Alpers DH, Blais JD, Smotzer DM, Krasa H, Ouyang J, Torres VE, Czerwiec FS, Zimmer CA. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Saf. 2015 Nov;38(11):1103-13. doi: 10.1007/s40264-015-0327-3.
- Torres VE, Meijer E, Bae KT, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang JJ, Czerwiec FS. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study. Am J Kidney Dis. 2011 May;57(5):692-9. doi: 10.1053/j.ajkd.2010.11.029. Epub 2011 Feb 17.
- Kher A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257-8. doi: 10.1056/NEJMc1300762. No abstract available.
- Spital A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257. doi: 10.1056/NEJMc1300762. No abstract available.
- Torres VE, Gansevoort RT, Czerwiec FS. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1259. doi: 10.1056/NEJMc1300762. No abstract available.
- Jouret F, Krzesinski JM. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258-9. doi: 10.1056/NEJMc1300762. No abstract available.
- Sexton DJ. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258. doi: 10.1056/NEJMc1300762. No abstract available.
- Nowak KL, Steele C, Gitomer B, Wang W, Ouyang J, Chonchol MB. Overweight and Obesity and Progression of ADPKD. Clin J Am Soc Nephrol. 2021 Jun;16(6):908-915. doi: 10.2215/CJN.16871020. Epub 2021 Jun 11.
- Heida JE, Gansevoort RT, Torres VE, Devuyst O, Perrone RD, Lee J, Li H, Ouyang J, Chapman AB. The Effect of Tolvaptan on BP in Polycystic Kidney Disease: A Post Hoc Analysis of the TEMPO 3:4 Trial. J Am Soc Nephrol. 2021 Jul;32(7):1801-1812. doi: 10.1681/ASN.2020101512. Epub 2021 Apr 22.
- McEwan P, Bennett Wilton H, Ong ACM, Orskov B, Sandford R, Scolari F, Cabrera MV, Walz G, O'Reilly K, Robinson P. A model to predict disease progression in patients with autosomal dominant polycystic kidney disease (ADPKD): the ADPKD Outcomes Model. BMC Nephrol. 2018 Feb 13;19(1):37. doi: 10.1186/s12882-017-0804-2.
- Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Dandurand A, Ouyang J, Czerwiec FS, Blais JD; TEMPO 4:4 Trial Investigators. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrol Dial Transplant. 2018 Mar 1;33(3):477-489. doi: 10.1093/ndt/gfx043.
- Muto S, Kawano H, Higashihara E, Narita I, Ubara Y, Matsuzaki T, Ouyang J, Torres VE, Horie S. The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. Clin Exp Nephrol. 2015 Oct;19(5):867-77. doi: 10.1007/s10157-015-1086-2. Epub 2015 Feb 7.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2007
Finalización primaria (Actual)
1 de enero de 2012
Finalización del estudio (Actual)
1 de enero de 2012
Fechas de registro del estudio
Enviado por primera vez
26 de enero de 2007
Primero enviado que cumplió con los criterios de control de calidad
29 de enero de 2007
Publicado por primera vez (Estimar)
30 de enero de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urológicas
- Anomalías congénitas
- Enfermedades Genéticas Congénitas
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Anomalías musculoesqueléticas
- Anomalías Múltiples
- Enfermedades Renales Quísticas
- Ciliopatías
- Enfermedades Renales
- Enfermedades renales poliquísticas
- Riñón Poliquístico, Autosómico Dominante
- Artrogriposis
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes natriuréticos
- Antagonistas del receptor de la hormona antidiurética
- Tolvaptán
Otros números de identificación del estudio
- 156-04-251
- 2006-002768-24 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .