Polycystic Kidney Disease, Autosomal Dominant Clinical Trial
— TEMPO3/4Official title:
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.
| Status | Completed |
| Enrollment | 1445 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - GFR estimated at =60 mL/ min - Diagnosis of ADPKD and rapidly progressive kidney growth (total volume =750 cc) by Magnetic Resonance Imaging (MRI) at randomization - Legal adult age and able to give Informed Consent - Willingness to comply with reproductive precautions if female 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay | Buenos Aires | |
| Argentina | Hosptial Universitario Austral | Buenos Aires | |
| Argentina | Instituto de Nefrología, Nefrology SA | Buenos Aires | |
| Argentina | Hospital Privado-Centro Medico de Cordoba | Cordoba | |
| Argentina | Sanatorio Allende | Cordoba | |
| Australia | Queen Elizebeth Hospital | Adelaide | |
| Australia | Royal Adelaide Hospital | Adelaide | |
| Australia | Princess Alexandra Hospital | Brisbane | |
| Australia | Melbourne Renal Research Group | Melbourne | |
| Australia | Royal Melbourne Hospital | Melbourne | |
| Australia | Royal Perth Hospital | Perth | |
| Australia | Royal North Shore Hospital | Sydney | |
| Australia | Westmead Hospital | Sydney | |
| Belgium | UZ Brussel | Brussel | |
| Belgium | Ucl-St Luc | Brussels | |
| Belgium | UZ Gent | Gent | |
| Canada | Queen Elizabeth II Health Science Center, Division of Nephrology | Halifax | Nova Scotia |
| Canada | Hospital du Sacre- Coeur de Montreal | Montreal | Quebec |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Denmark | Herlev Amtssygehus | Herlev | |
| Denmark | Odense Universitetshospital | Odense | |
| France | CHU-Hopital Pellegrin | Bordeaux | |
| France | CHU - Hôpital Clémenceau | Caen Cedex | |
| France | Hôpital Edouard Herriot | Lyon Cedex 3 | |
| France | Hôpital de la Conception | Marseille | |
| France | CHU - Hôpital Lapeyronie | Montpellier | |
| France | Hopital Bichat-Claude Bernard | Paris | |
| France | Centre Hospitalier Universitaire | Reims cedex | |
| France | CHU - Hôpital Nord | Saint-Etienne Cedex 2 | |
| France | Hopital Rangueil | Toulouse Cedex 09 | |
| Germany | Universitätsklinikum Carl Gustav Carus | Dresden | |
| Germany | Nephrologische Gemeinschaftspraxis/Dialysezentrum | Düsseldorf | |
| Germany | Klinik für Nieren- und Hochdruckkrankheiten | Essen | |
| Germany | Universitätsklinikum Freiburg | Freiburg | |
| Germany | Universitätskliniken Heidelberg | Heidelberg | |
| Germany | UH Erlangen/Nürnberg | Nuernberg | |
| Italy | Ospedali Riuniti di Bergamo | Bergamo | |
| Italy | Università Vita e Salute, Ospedale San Raffaele | Milano | |
| Italy | Policlinico di Modena | Modena | |
| Italy | Policlinico | Napoli | |
| Italy | IRCCS Fondazione Salvatore Maugeri | Pavia | |
| Japan | Nippon Medical School Hospital | Bunkyo-ku | Tokyo |
| Japan | Tokyo Medical & Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo |
| Japan | Chiba University Hospital | Chiba | |
| Japan | National Hospital Organization Chiba-East Hospital | Chiba | |
| Japan | Kyusyu University Hospital | Fukuoka | |
| Japan | Fukushima Medical University Hospital | Fukushima | |
| Japan | Hamamatsu University School of Medicine, University Hospital | Hamamatsu | Shizuoka |
| Japan | Hiroshima University Hospital | Hiroshima | |
| Japan | Tokai University Hospital | Isehara | Kanagawa |
| Japan | Teikyo University Hospital | Itabashi-ku | Tokyo |
| Japan | Shuwa General Hospital | Kasukabe | Saitama |
| Japan | Saitama Medical Center | Kawagoe | Saitama |
| Japan | Toranomon Hospital Kajigaya | Kawasaki | Kanagawa |
| Japan | Kumamoto Univeristy Hospital | Kumamoto | |
| Japan | Kyoto University Hospital | Kyoto | |
| Japan | National Hospital Organization Kyoto Medical Center | Kyoto | |
| Japan | The Jikei University Hospital | Minato-Ku | Tokyo |
| Japan | Toranomon Hospital | Minato-ku | Tokyo |
| Japan | Kyorin University Hospital | Mitaka | Tokyo |
| Japan | Niigata University Medical & Dental Hospital | Niigata | |
| Japan | Ohno Memorial Hospital | Osaka | |
| Japan | Osaka City University Hospital | Osaka-City | Osaka |
| Japan | Kitasato University Hospital | Sagamihara | Kanagawa |
| Japan | Saitama Medical Center Jichi Medical University | Saitama | |
| Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
| Japan | Tohoku University Hospital | Sendai | Miyagi |
| Japan | Jichi Medical School Hospital | Shimotsuke | Tochigi |
| Japan | Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo |
| Japan | Osaka University Hospital | Suita | Osaka |
| Japan | Fujita Health University Hospital | Toyoake | Aichi |
| Netherlands | VU Medisch Centrum | Amsterdam | |
| Netherlands | UMCG Groningen | Groningen | |
| Poland | Oddzial Nefrologiczny Stacja Dializ | Ciechanow | |
| Poland | Akademickie Centrum Kliniczne AMG | Gdansk | |
| Poland | Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG | Gdansk | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie | Krakow | |
| Poland | SOP ZOZ Uniwersytecki Szpital Kliniczny | Lodz | |
| Poland | Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | |
| Poland | Klinika Chorób Wewnetrznych i Nefrologii | Warsaw | |
| Poland | Miedzyleski Szpital Specjalistyczny w Warszawie | Warsaw | |
| Poland | Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Warszawa | |
| Poland | Szpital Praski, Samodzielny Publiczny ZOZ | Warszawa | |
| Poland | Akademicki Szpital Kliniczny im J Mikulicza Radeckiego | Wroclaw | |
| Romania | Institutul Clinic Fundeni | Bucharest | |
| Romania | Spitalul Clinic de Nefrologie Dr. Carol Davila | Bucharest | |
| Romania | Spitalul Clinic "C.I.Parhon" | Iasi | |
| Russian Federation | Kemerovo Medical Academy, Regional Clinical Hospital | Kemerovo | |
| Russian Federation | City Clinical Hospital #52 | Moscow | |
| Russian Federation | City Mariinskiy Hospital | St. Petersburg | |
| Russian Federation | Leningrad Regional Clinical Hospital | St.-Petersburg | |
| Russian Federation | Tomsk Regional Clinical Hospital | Tomsk | |
| United Kingdom | Belfast City Hospital | Belfast | |
| United Kingdom | Oueen Elizabeth Hospital | Birmingham | |
| United Kingdom | Sussex Renal Unit Royal Sussex County Hospital | Brighton | |
| United Kingdom | Uhcw Mhs Trust | Coventry | |
| United Kingdom | Royal Infirmary | Edinburgh | |
| United Kingdom | Raigmore Hospital | Inverness | |
| United Kingdom | King's College Hospital | London | |
| United Kingdom | Royal Free and University College Medical School | London | |
| United Kingdom | St. George's Hospital | London | |
| United Kingdom | Royal Hallamshire Hospital | Sheffield | |
| United Kingdom | Morriston Hospital | Swansea | |
| United States | Emory University School of Medicine | Atlanta | Georgia |
| United States | John Hopkins School of Medicine | Baltimore | Maryland |
| United States | Renal Associates of Baton Rough, L.L.C. | Baton Rouge | Louisiana |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Tufts- New England Medical Center | Boston | Massachusetts |
| United States | Erie County Medical Center | Buffalo | New York |
| United States | University of North Carolina, UNC, Kidney Center | Chapel Hill | North Carolina |
| United States | Charleston Nephrology Associates | Charleston | South Carolina |
| United States | University of Virginia, Nephrology Clinical Research Center | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | Kidney and Hypertension Center | Cincinnati | Ohio |
| United States | University Hospitals of Cleveland/Case | Cleveland | Ohio |
| United States | University of Colorado Health Sciences Center | Denver | Colorado |
| United States | East Carolina University | Greenville | North Carolina |
| United States | Nephrology Associates of Westchester | Hawthorne | New York |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Coastal Clinical Research | Mobile | Alabama |
| United States | University of South Alabama | Mobile | Alabama |
| United States | Nephrology Associates, P.C. | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Columbia University Medical Center | New York | New York |
| United States | The Rogosin Institute | New York | New York |
| United States | University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
| United States | Coastal Nephrology Associates Research Center, LLC | Port Charlotte | Florida |
| United States | Northwest Renal Clinic, Inc. | Portland | Oregon |
| United States | Apex Research of Riverside | Riverside | California |
| United States | Mayo Medical Center | Rochester | Minnesota |
| United States | Stanford University Medical Center | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. |
United States, Argentina, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Romania, Russian Federation, United Kingdom,
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. Epub 2003 Sep 21. — View Citation
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. Epub 2004 Feb 29. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of total kidney volume change(%) | 36 months | No | |
| Secondary | Time to onset of multiple ADPKD outcomes | ADPKD outcomes include new onset hypertension, worsening hypertension, renal pain, worsening albuminuria and worsening renal function | 36 months | No |
| Secondary | Evaluate long-term efficacy of tolvaptan in ADPKD using single clinical 4-markers of ADPKD progression | 36 months | No | |
| Secondary | Evaluate long-term safety of tolvaptan through standard clinical measures. | 36 months | Yes | |
| Secondary | Evaluate pharmacokinetic (PK), pharmacodynamic (PD) and exploratory parameters for tolvaptan in ADPKD. | 36 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04536688 -
A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease
|
Phase 1 |