Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD (TEMPO3/4)
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00428948
First received: January 26, 2007
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Kidney Disease, Autosomal Dominant |
Drug: tolvaptan Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
polycystic kidney disease
Drug Information available for:
Tolvaptan
U.S. FDA Resources
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Rate of total kidney volume change(%) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to onset of multiple ADPKD outcomes [ Time Frame: 36 months ] [ Designated as safety issue: No ]ADPKD outcomes include new onset hypertension, worsening hypertension, renal pain, worsening albuminuria and worsening renal function
- Evaluate long-term efficacy of tolvaptan in ADPKD using single clinical 4-markers of ADPKD progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Evaluate long-term safety of tolvaptan through standard clinical measures. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Evaluate pharmacokinetic (PK), pharmacodynamic (PD) and exploratory parameters for tolvaptan in ADPKD. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 1445 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tolvaptan |
Drug: tolvaptan
oral tablet split-dose regimens (45/15mg, 60/30 mg or 90/30 mg) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.
Other Name: OPC-41061 or OPC-156
|
| Placebo Comparator: Placebo |
Drug: Placebo
oral tablet split-dose regimens (45/15mg Placebo, 60/30 mg Placebo or 90/30 mg Placebo) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.
|
Detailed Description:
The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total renal volume increase, while impacting the onset, severity and progression of other important consequences of ADPKD.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428948
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| United States, Alabama | |
| University of South Alabama | |
| Mobile, Alabama, United States, 36617 | |
| Coastal Clinical Research | |
| Mobile, Alabama, United States, 36608 | |
| United States, California | |
| Apex Research of Riverside | |
| Riverside, California, United States, 92503 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5114 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Coastal Nephrology Associates Research Center, LLC | |
| Port Charlotte, Florida, United States, 33952 | |
| United States, Georgia | |
| Emory University School of Medicine | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| Renal Associates of Baton Rough, L.L.C. | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| John Hopkins School of Medicine | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Tufts- New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Mayo Medical Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Erie County Medical Center | |
| Buffalo, New York, United States, 14215 | |
| Nephrology Associates of Westchester | |
| Hawthorne, New York, United States, 10532 | |
| The Rogosin Institute | |
| New York, New York, United States, 10021 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| University of North Carolina, UNC, Kidney Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| East Carolina University | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Kidney and Hypertension Center | |
| Cincinnati, Ohio, United States, 45220 | |
| University Hospitals of Cleveland/Case | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Northwest Renal Clinic, Inc. | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Charleston Nephrology Associates | |
| Charleston, South Carolina, United States, 29405 | |
| United States, Tennessee | |
| Nephrology Associates, P.C. | |
| Nashville, Tennessee, United States, 37205 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232-1371 | |
| United States, Virginia | |
| University of Virginia, Nephrology Clinical Research Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Argentina | |
| Instituto de Nefrología, Nefrology SA | |
| Buenos Aires, Argentina, 1425 | |
| Hosptial Universitario Austral | |
| Buenos Aires, Argentina, B1664INZ | |
| Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay | |
| Buenos Aires, Argentina, 1602 | |
| Hospital Privado-Centro Medico de Cordoba | |
| Cordoba, Argentina, X5016KEA | |
| Sanatorio Allende | |
| Cordoba, Argentina, X5000IUP | |
| Australia | |
| Royal Adelaide Hospital | |
| Adelaide, Australia, 5000 | |
| Queen Elizebeth Hospital | |
| Adelaide, Australia, 5011 | |
| Princess Alexandra Hospital | |
| Brisbane, Australia, 4102 | |
| Melbourne Renal Research Group | |
| Melbourne, Australia, 3121 | |
| Royal Melbourne Hospital | |
| Melbourne, Australia, 3050 | |
| Royal Perth Hospital | |
| Perth, Australia, 6054 | |
| Royal North Shore Hospital | |
| Sydney, Australia, 2065 | |
| Westmead Hospital | |
| Sydney, Australia, 2145 | |
| Belgium | |
| UZ Brussel | |
| Brussel, Belgium, 1090 | |
| Ucl-St Luc | |
| Brussels, Belgium, 1200 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Science Center, Division of Nephrology | |
| Halifax, Nova Scotia, Canada, B3H1v8 | |
| Canada, Quebec | |
| Hospital du Sacre- Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J1C5 | |
| Royal Victoria Hospital | |
| Montreal, Quebec, Canada, H3A1A1 | |
| Denmark | |
| Herlev Amtssygehus | |
| Herlev, Denmark, 2730 | |
| Odense Universitetshospital | |
| Odense, Denmark, 5000 | |
| France | |
| CHU-Hopital Pellegrin | |
| Bordeaux, France, 33076 | |
| CHU - Hôpital Clémenceau | |
| Caen Cedex, France, 14033 | |
| Hôpital Edouard Herriot | |
| Lyon Cedex 3, France, 69437 | |
| Hôpital de la Conception | |
| Marseille, France, 13005 | |
| CHU - Hôpital Lapeyronie | |
| Montpellier, France, 34295 | |
| Hopital Bichat-Claude Bernard | |
| Paris, France, 75018 | |
| Centre Hospitalier Universitaire | |
| Reims cedex, France, 51092 | |
| CHU - Hôpital Nord | |
| Saint-Etienne Cedex 2, France, 42055 | |
| Hopital Rangueil | |
| Toulouse Cedex 09, France, 31059 | |
| Germany | |
| Universitätsklinikum Carl Gustav Carus | |
| Dresden, Germany, 1307 | |
| Nephrologische Gemeinschaftspraxis/Dialysezentrum | |
| Düsseldorf, Germany, 40210 | |
| Klinik für Nieren- und Hochdruckkrankheiten | |
| Essen, Germany, 45147 | |
| Universitätsklinikum Freiburg | |
| Freiburg, Germany, 78106 | |
| Universitätskliniken Heidelberg | |
| Heidelberg, Germany, 69120 | |
| UH Erlangen/Nürnberg | |
| Nuernberg, Germany, 90471 | |
| Italy | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24128 | |
| Università Vita e Salute, Ospedale San Raffaele | |
| Milano, Italy, 20132 | |
| Policlinico di Modena | |
| Modena, Italy, 41100 | |
| Policlinico | |
| Napoli, Italy, 80131 | |
| IRCCS Fondazione Salvatore Maugeri | |
| Pavia, Italy, 27100 | |
| Japan | |
| Fujita Health University Hospital | |
| Toyoake, Aichi, Japan, 4701192 | |
| Hokkaido University Hospital | |
| Sapporo, Hokkaido, Japan, 608648 | |
| Tokai University Hospital | |
| Isehara, Kanagawa, Japan, 2591193 | |
| Toranomon Hospital Kajigaya | |
| Kawasaki, Kanagawa, Japan, 2138587 | |
| Kitasato University Hospital | |
| Sagamihara, Kanagawa, Japan, 2288555 | |
| Tohoku University Hospital | |
| Sendai, Miyagi, Japan, 9808574 | |
| Osaka City University Hospital | |
| Osaka-City, Osaka, Japan, 5458586 | |
| Osaka University Hospital | |
| Suita, Osaka, Japan, 5650871 | |
| Shuwa General Hospital | |
| Kasukabe, Saitama, Japan, 3440035 | |
| Saitama Medical Center | |
| Kawagoe, Saitama, Japan, 3508500 | |
| Hamamatsu University School of Medicine, University Hospital | |
| Hamamatsu, Shizuoka, Japan, 4313192 | |
| Jichi Medical School Hospital | |
| Shimotsuke, Tochigi, Japan, 3290498 | |
| Tokyo Medical & Dental University Hospital, Faculty of Medicine | |
| Bunkyo-ku, Tokyo, Japan, 1138519 | |
| Nippon Medical School Hospital | |
| Bunkyo-ku, Tokyo, Japan, 1138603 | |
| Teikyo University Hospital | |
| Itabashi-ku, Tokyo, Japan, 1738606 | |
| Toranomon Hospital | |
| Minato-ku, Tokyo, Japan, 1058470 | |
| The Jikei University Hospital | |
| Minato-Ku, Tokyo, Japan, 1058471 | |
| Kyorin University Hospital | |
| Mitaka, Tokyo, Japan, 1818611 | |
| Tokyo Women's Medical University Hospital | |
| Shinjuku-ku, Tokyo, Japan, 1628666 | |
| Chiba University Hospital | |
| Chiba, Japan, 2608677 | |
| National Hospital Organization Chiba-East Hospital | |
| Chiba, Japan, 2608712 | |
| Kyusyu University Hospital | |
| Fukuoka, Japan, 8128582 | |
| Fukushima Medical University Hospital | |
| Fukushima, Japan, 9601295 | |
| Hiroshima University Hospital | |
| Hiroshima, Japan, 7348551 | |
| Kumamoto Univeristy Hospital | |
| Kumamoto, Japan, 8608556 | |
| Kyoto University Hospital | |
| Kyoto, Japan, 6068507 | |
| National Hospital Organization Kyoto Medical Center | |
| Kyoto, Japan, 612-8555 | |
| Niigata University Medical & Dental Hospital | |
| Niigata, Japan, 9518520 | |
| Ohno Memorial Hospital | |
| Osaka, Japan, 5500015 | |
| Saitama Medical Center Jichi Medical University | |
| Saitama, Japan, 3308503 | |
| Netherlands | |
| VU Medisch Centrum | |
| Amsterdam, Netherlands, 1081 HV | |
| UMCG Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Poland | |
| Oddział Nefrologiczny Stacja Dializ | |
| Ciechanow, Poland, 06-400 | |
| Akademickie Centrum Kliniczne AMG | |
| Gdansk, Poland, 80-952 | |
| Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG | |
| Gdansk, Poland, 80-952 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie | |
| Krakow, Poland, 31-501 | |
| SOP ZOZ Uniwersytecki Szpital Kliniczny | |
| Lodz, Poland, 90-153 | |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | |
| Lublin, Poland, 20-954 | |
| Klinika Chorób Wewnętrznych i Nefrologii | |
| Warsaw, Poland, 02-507 | |
| Międzyleski Szpital Specjalistyczny w Warszawie | |
| Warsaw, Poland, 04-749 | |
| Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Warszawa, Poland, 03-401 | |
| Szpital Praski, Samodzielny Publiczny ZOZ | |
| Warszawa, Poland, 03-401 | |
| Akademicki Szpital Kliniczny im J Mikulicza Radeckiego | |
| Wroclaw, Poland, 50-417 | |
| Romania | |
| Spitalul Clinic de Nefrologie Dr. Carol Davila | |
| Bucharest, Romania, 10731 | |
| Institutul Clinic Fundeni | |
| Bucharest, Romania, 22328 | |
| Spitalul Clinic "C.I.Parhon" | |
| Iasi, Romania, 700503 | |
| Russian Federation | |
| Kemerovo Medical Academy, Regional Clinical Hospital | |
| Kemerovo, Russian Federation, 650061 | |
| City Clinical Hospital #52 | |
| Moscow, Russian Federation, 123060 | |
| City Mariinskiy Hospital | |
| St. Petersburg, Russian Federation, 191104 | |
| Leningrad Regional Clinical Hospital | |
| St.-Petersburg, Russian Federation, 194291 | |
| Tomsk Regional Clinical Hospital | |
| Tomsk, Russian Federation, 634063 | |
| United Kingdom | |
| Belfast City Hospital | |
| Belfast, United Kingdom, BT9 7AB | |
| Oueen Elizabeth Hospital | |
| Birmingham, United Kingdom, B15 2TH | |
| Sussex Renal Unit Royal Sussex County Hospital | |
| Brighton, United Kingdom, BN2 5BE | |
| Uhcw Mhs Trust | |
| Coventry, United Kingdom, CV2 2DX | |
| Royal Infirmary | |
| Edinburgh, United Kingdom, EH16 4SA | |
| Raigmore Hospital | |
| Inverness, United Kingdom, IV2 3UJ | |
| King's College Hospital | |
| London, United Kingdom, SE5-9RS | |
| St. George's Hospital | |
| London, United Kingdom, SW170RE | |
| Royal Free and University College Medical School | |
| London, United Kingdom, NW3 2PF | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom, S5 7AU | |
| Morriston Hospital | |
| Swansea, United Kingdom, SA6 6NL | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | Vicente Torres, MD, PhD | Mayo Medical Center |
| Study Director: | Frank Czerwiec, MD, PhD | Otsuka Pharmaceutical Development and Commercialization, Inc. |
| Study Director: | Osamu Sato | Otsuka Pharmaceutical Corporation, Ltd. Japan |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT00428948 History of Changes |
| Other Study ID Numbers: | 156-04-251, 2006-002768-24 |
| Study First Received: | January 26, 2007 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Argentina: Ministry of Health Australia: Human Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency France: National Consultative Ethics Committee for Health and Life Sciences Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Belgium: Ethics Committee Netherlands: Independent Ethics Committee Poland: Ethics Committee Romania: Ethics Committee Russia: Ethics Committee Japan: Ministry of Health, Labor and Welfare Denmark: National Board of Health |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
ADPKD Polycystic kidney ADPKD (Autosomal Dominant Polycystic Kidney Disease) |
Additional relevant MeSH terms:
|
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Kidney Diseases, Cystic |
ClinicalTrials.gov processed this record on May 16, 2013