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Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02251275
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of the study is to evaluate and describe the long term safety of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Drug: Tolvaptan (OPC-41061) Phase 3

Detailed Description:
This trial is a phase 3b to evaluate and describe the long-term safety of tolvaptan treatment in ADPKD patients with CKD (chronic kidney disease). Eligible Subjects will enter the trial from Trial 156-08-271 or other Tolvaptan interventional trials. Renal function will be assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR). General safety endpoints will be assessed and also relevant safety endpoints for the trial as Serum transaminase elevations in frequency & Serum sodium excursions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1814 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease
Study Start Date : September 2014
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: Tolvaptan (OPC-41061) Drug: Tolvaptan (OPC-41061)
Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later




Primary Outcome Measures :
  1. Safety variables [ Time Frame: From Baseline ]

    Clinically significant changes from baseline in abnormal clinical laboratory tests, vital signs and AEs will be summarized.The incidence of the following events will be summarized:

    1. Treatment-emergent AEs (TEAEs) by severity
    2. TEAEs potentially causally related to tolvaptan
    3. TEAEs with an outcome of death
    4. Serious TEAEs
    5. Discontinuations due to TEAEs

    Clinically significant serum transaminase elevations will be summarized by frequency (2x, 3x, 5x and 10x ULN), time to onset, time to peak levels, time to offset (< 3x, 2x, or 1x ULN)

    Frequency of progression to Hy's laboratory criteria (ALT or AST > 3x ULN and bilirubin, total (BT), > 2x ULN without alkaline phosphatase > 2x ULN)

    Serum sodium excursions above 145, 150, or 155 mmol/L or below 135, 130, or 125 mmol/L




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects ≥ 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have

    • Completed and transferred from the double-blind Trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or
    • Completed Trial 156-08-271 or a prior tolvaptan trial, or
    • Interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than Trial 156-13-210. Subjects may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the study
  2. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m2 within 45 days of the baseline visit. Subjects who have an eGFR between 15 and 19 mL/min/1.73m2 may be enrolled with medical monitor approval
  3. Diagnosis of ADPKD by modified Pei-Ravine criteria

Exclusion Criteria:

  • Need for chronic diuretic use
  • Hepatic impairment based on liver function assessments other than that expected for ADPKD with cystic liver disease
  • Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP
  • Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
  • Subjects with contraindications to required trial assessments (contraindications to optional assessments, eg, MRI are not a limitation).
  • Subjects who in the opinion of the Investigator or the Medical Monitor, have a medical history or medical finding inconsistent with safety or trial compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251275


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35216
Huntsville, Alabama, United States, 35805
Mobile, Alabama, United States, 36617
United States, Arizona
Phoenix, Arizona, United States, 85381
Tempe, Arizona, United States, 85284
Tucson, Arizona, United States, 85745
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90025
San Francisco, California, United States, 94143
Stanford, California, United States, 94305
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80204
Denver, Colorado, United States, 80210
Denver, Colorado, United States, 80220
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Florida
Hudson, Florida, United States, 34667
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33150
Ocala, Florida, United States, 34471
Port Charlotte, Florida, United States, 33952
Tampa, Florida, United States, 33609
United States, Georgia
Atlanta, Georgia, United States, 30322
Augusta, Georgia, United States, 30909
United States, Idaho
Caldwell, Idaho, United States, 836035
Meridian, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60611-2098
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas City, Kansas, United States, 66160
Wichita, Kansas, United States, 67214
United States, Louisiana
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Baltimore, Maryland, United States, 21224
Greenbelt, Maryland, United States, 20770
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Western New England Renal & Transplant Associates, PC
Springfield, Massachusetts, United States, 01107
United States, Michigan
Battle Creek, Michigan, United States, 49017
Detroit, Michigan, United States, 48202
Detroit, Michigan, United States, 48236
Grand Rapids, Michigan, United States, 49506
Kalamazoo, Michigan, United States, 49007
Pontiac, Michigan, United States, 48341
Roseville, Michigan, United States, 48066
United States, Minnesota
Minneapolis, Minnesota, United States, 55404
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89128
Sparks, Nevada, United States, 89434
United States, New Jersey
Eatontown, New Jersey, United States, 07724
Nephrology and Hypertension Associates of NJ
Voorhees, New Jersey, United States, 08043
United States, New York
Buffalo, New York, United States, 14215
Laurelton, New York, United States, 11413
Winthrop Internal Medicine Associates
Mineola, New York, United States, 11501
New York, New York, United States, 10003
New York, New York, United States, 10021
New York, New York, United States, 10032
Rosedale, New York, United States, 11422
United States, North Carolina
Asheville, North Carolina, United States, 28801
Chapel Hill, North Carolina, United States, 27599
Metrolina Nephrology Associates
Charlotte, North Carolina, United States, 28207
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron, Ohio, United States, 44307
Cincinnati, Ohio, United States, 45229
Cincinnati, Ohio, United States, 45267
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43210
Ohio State University Clinical Trials Management Office
Dublin, Ohio, United States, 43017
United States, Oregon
Portland, Oregon, United States, 97210
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18017
Doylestown, Pennsylvania, United States, 18901
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Charleston, South Carolina, United States, 29425
Columbia Nephrology Associates
Columbia, South Carolina, United States, 29201
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Knoxville, Tennessee, United States, 37923
Nashville, Tennessee, United States, 37205
Nashville, Tennessee, United States, 37232
United States, Texas
Arlington, Texas, United States, 76015
Edinburg, Texas, United States, 78539
Houston, Texas, United States, 77030
McAllen, Texas, United States, 78503
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Arlington, Virginia, United States, 22205
Charlottesville, Virginia, United States, 22908
Norfolk, Virginia, United States, 23507
United States, Washington
Wenatchee, Washington, United States, 98801
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Argentina
Junin, Buenos Aires, Argentina, 6000
Pergamino, Buenos Aires, Argentina, B2700CPM
Pilar, Buenos Aires, Argentina, B1629ODT
Sarandi, Buenos Aires, Argentina, B1872EEA
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1429BWN
Ciudad Autonoma Buenos Aires, Argentina, 1425
Ciudad Autonoma Buenos Aires, Argentina, C1093AAS
Ciudad Autonoma Buenos Aires, Argentina, C1431FWO
Cordoba, Argentina, X5000JHQ
Cordoba, Argentina, X5016KEH
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
New Lambton Heights, New South Wales, Australia, 2305
St Leonards, New South Wales, Australia, 2065
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Melbourne, Victoria, Australia, 3050
Reservoir, Victoria, Australia, 3073
Richmond, Victoria, Australia, 3121
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Belgium
Aalst, Belgium, 9300
Bruxelles, Belgium, 1090
Bruxelles, Belgium, 1200
Edegem, Belgium, 2650
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
C. H. R. de la Citadelle
Liège, Belgium, 4000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, NL A1B 3V6
Canada, Ontario
Scarborough, Ontario, Canada, M1H 3G4
Toronto, Ontario, Canada, M4C 5T2
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H4J 1C5
Czechia
Brno, Czechia, 625 00
Ceske Budejovice, Czechia, 370 01
Hradec Kralove, Czechia, 500 05
Jihlava, Czechia, 586 01
Jilemnice, Czechia, 51401
Liberec, Czechia, 460 63
Ostrava, Czechia, 708 52
Praha 2, Czechia, 128 08
Praha 4, Czechia, 140 21
Denmark
Aahus C, Denmark, 8000
Aalborg, Denmark, 9100
Holstebro, Denmark, 7500
Germany
Heidelberg, Baden Wuerttemberg, Germany, 69120
Muenchen, Bayern, Germany, 81675
Nuernberg, Bayern, Germany, 90471
Nierenzentrum Wiesbaden
Wiesbaden, Hessen, Germany, 65191
Duesseldorf, Nordrhein Westfalen, Germany, 40210
Essen, Nordrhein Westfalen, Germany, 45147
Dresden, Sachsen, Germany, 01307
Berlin, Germany, 10117
Hungary
Budapest, Hungary, 1032
Pecs, Hungary, 7623
Szeged, Hungary, 6720
Israel
Ashkelon, Israel, 7830604
Nahariya, Israel, 22100
Petach Tikva, Israel, 4941492
Ramat-Gan, Israel, 52621
Tel Aviv, Israel, 64239
Italy
Montichiari, Brescia, Italy, 25018
Bari, Italy, 70124
Lecco, Italy, 23900
Milano, Italy, 20122
Milano, Italy, 20132
Modena, Italy, 41124
Napoli, Italy, 80138
Pavia, Italy, 27100
Netherlands
Amsterdam, Netherlands, 1081 HV
Groningen, Netherlands, 9713 GZ
Nijmegen, Netherlands, 6525 GA
Norway
Bergen, Norway, 5021
Poland
Ciechanow, Poland, 06-400
Gdansk, Poland, 80-952
Golub Dobrzyn, Poland, 87-400
Krakow, Poland, 31-559
Lodz, Poland, 90-153
Lodz, Poland, 93-316
Lublin, Poland, 20-954
Szczecin, Poland, 70-111
Warszawa, Poland, 04-749
Wroclaw, Poland, 50-556
Romania
Bucuresti, Romania, 010731
Bucuresti, Romania, 011794
Bucuresti, Romania, 022328
Oradea, Romania, 410469
Russian Federation
Kemerovo, Russian Federation, 650002
Krasnoyarsk, Russian Federation, 660062
Saint-Petersburg, Russian Federation, 194044
Saint-Petersburg, Russian Federation, 197022
Yaroslavl, Russian Federation, 150062
South Africa
Pretoria, Gauteng, South Africa, 0002
Durban, KwaZulu-Natal, South Africa, 4001
Cape Town, Western Cape, South Africa, 7925
Spain
Barcelona, Spain, 08907
Ciudad Real, Spain, 13005
Madrid, Spain, 28041
Madrid, Spain, 28046
Valencia, Spain, 46017
Sweden
Sahlgrenska Sjukhuset
Göteborg, Sweden, 413 45
Universitetssjukhuset Linköping
Linköping, Sweden, 58185
Stockholm, Sweden, 14186
Stockholm, Sweden, 17176
Uppsala, Sweden, 75185
United Kingdom
Belfast, County Antrim, United Kingdom, BT9 7BL
Exeter, Devon, United Kingdom, EX2 5DW
Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
Brighton, East Sussex, United Kingdom, BN2 5BE
London, Greater London, United Kingdom, NW3 2QG
London, Greater London, United Kingdom, SE5 9NU
London, Greater London, United Kingdom, SW17 0QT
Manchester, Greater Manchester, United Kingdom, M13 9WL
Salford, Greater Manchester, United Kingdom, M6 8HD
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Inverness, Highland Region, United Kingdom, IV2 3UJ
Leicester, Leicestershire, United Kingdom, LE5 4PW
Edinburgh, Lothian Region, United Kingdom, EH16 4SA
Liverpool, Norfolk, United Kingdom, L7 8XP
Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
Coventry, Warwickshire, United Kingdom, CV2 2DX
Birmingham, West Midlands, United Kingdom, B15 2WB
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02251275     History of Changes
Other Study ID Numbers: 156-13-211
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Autosomal Dominant Polycystic Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs