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Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (TEMPO3:4)

Primary Purpose

Polycystic Kidney Disease, Autosomal Dominant

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolvaptan
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Kidney Disease, Autosomal Dominant focused on measuring ADPKD, Polycystic, kidney, ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Coastal Clinical Research
  • University of South Alabama
  • Apex Research of Riverside
  • Stanford University Medical Center
  • University of Colorado Health Sciences Center
  • Yale University School of Medicine
  • Jacksonville Center for Clinical Research
  • Coastal Nephrology Associates Research Center, LLC
  • Emory University School of Medicine
  • Northwestern University
  • University of Kansas Medical Center
  • Renal Associates of Baton Rough, L.L.C.
  • John Hopkins School of Medicine
  • Tufts- New England Medical Center
  • Beth Israel Deaconess Medical Center
  • Mayo Medical Center
  • Erie County Medical Center
  • Nephrology Associates of Westchester
  • The Rogosin Institute
  • Columbia University Medical Center
  • University of North Carolina, UNC, Kidney Center
  • East Carolina University
  • Kidney and Hypertension Center
  • University Hospitals of Cleveland/Case
  • Northwest Renal Clinic, Inc.
  • University of Pennsylvania Medical Center
  • Charleston Nephrology Associates
  • Nephrology Associates, P.C.
  • Vanderbilt University Medical Center
  • University of Virginia, Nephrology Clinical Research Center
  • Instituto de Nefrología, Nefrology SA
  • Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay
  • Hosptial Universitario Austral
  • Sanatorio Allende
  • Hospital Privado-Centro Medico de Cordoba
  • Royal Adelaide Hospital
  • Queen Elizebeth Hospital
  • Princess Alexandra Hospital
  • Royal Melbourne Hospital
  • Melbourne Renal Research Group
  • Royal Perth Hospital
  • Royal North Shore Hospital
  • Westmead Hospital
  • Ucl-St Luc
  • UZ Brussel
  • UZ Gent
  • Queen Elizabeth II Health Science Center, Division of Nephrology
  • Royal Victoria Hospital
  • Hospital du Sacre- Coeur de Montreal
  • Herlev Amtssygehus
  • Odense Universitetshospital
  • CHU-Hopital Pellegrin
  • CHU - Hôpital Clémenceau
  • Hôpital Edouard Herriot
  • Hôpital de la Conception
  • CHU - Hôpital Lapeyronie
  • Hopital Bichat-Claude Bernard
  • Centre Hospitalier Universitaire
  • CHU - Hôpital Nord
  • Hopital Rangueil
  • Universitätsklinikum Carl Gustav Carus
  • Nephrologische Gemeinschaftspraxis/Dialysezentrum
  • Klinik für Nieren- und Hochdruckkrankheiten
  • Universitätsklinikum Freiburg
  • Universitätskliniken Heidelberg
  • UH Erlangen/Nürnberg
  • Ospedali Riuniti di Bergamo
  • Università Vita e Salute, Ospedale San Raffaele
  • Policlinico di Modena
  • Policlinico
  • IRCCS Fondazione Salvatore Maugeri
  • Fujita Health University Hospital
  • Hokkaido University Hospital
  • Tokai University Hospital
  • Toranomon Hospital Kajigaya
  • Kitasato University Hospital
  • Tohoku University Hospital
  • Osaka City University Hospital
  • Osaka University Hospital
  • Shuwa General Hospital
  • Saitama Medical Center
  • Hamamatsu University School of Medicine, University Hospital
  • Jichi Medical School Hospital
  • Tokyo Medical & Dental University Hospital, Faculty of Medicine
  • Nippon Medical School Hospital
  • Teikyo University Hospital
  • Toranomon Hospital
  • The Jikei University Hospital
  • Kyorin University Hospital
  • Tokyo Women's Medical University Hospital
  • Chiba University Hospital
  • National Hospital Organization Chiba-East Hospital
  • Kyusyu University Hospital
  • Fukushima Medical University Hospital
  • Hiroshima University Hospital
  • Kumamoto Univeristy Hospital
  • Kyoto University Hospital
  • National Hospital Organization Kyoto Medical Center
  • Niigata University Medical & Dental Hospital
  • Ohno Memorial Hospital
  • Saitama Medical Center Jichi Medical University
  • VU Medisch Centrum
  • UMCG Groningen
  • Oddział Nefrologiczny Stacja Dializ
  • Akademickie Centrum Kliniczne AMG
  • Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie
  • SOP ZOZ Uniwersytecki Szpital Kliniczny
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Klinika Chorób Wewnętrznych i Nefrologii
  • Międzyleski Szpital Specjalistyczny w Warszawie
  • Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Szpital Praski, Samodzielny Publiczny ZOZ
  • Akademicki Szpital Kliniczny im J Mikulicza Radeckiego
  • Spitalul Clinic de Nefrologie Dr. Carol Davila
  • Institutul Clinic Fundeni
  • Spitalul Clinic "C.I.Parhon"
  • Kemerovo Medical Academy, Regional Clinical Hospital
  • City Clinical Hospital #52
  • City Mariinskiy Hospital
  • Leningrad Regional Clinical Hospital
  • Tomsk Regional Clinical Hospital
  • Belfast City Hospital
  • Oueen Elizabeth Hospital
  • Sussex Renal Unit Royal Sussex County Hospital
  • Uhcw Mhs Trust
  • Royal Infirmary
  • Raigmore Hospital
  • Royal Free and University College Medical School
  • King's College Hospital
  • St. George's Hospital
  • Royal Hallamshire Hospital
  • Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tolvaptan

Placebo

Arm Description

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.

Participants received placebo (upon awakening and 9 hours later) orally for 36 months.

Outcomes

Primary Outcome Measures

Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
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.

Secondary Outcome Measures

Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36
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.
Change in Renal Function Per Year From Week 3 to Month 36
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.
Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36
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.
Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36
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.
Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36
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.
Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36

Full Information

First Posted
January 26, 2007
Last Updated
May 30, 2017
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00428948
Brief Title
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Acronym
TEMPO3:4
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney Disease, Autosomal Dominant
Keywords
ADPKD, Polycystic, kidney, ADPKD (Autosomal Dominant Polycystic Kidney Disease)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
OPC-41061, OPC-156
Intervention Description
Tolvaptan was supplied as tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied as tablets.
Primary Outcome Measure Information:
Title
Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
Description
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.
Time Frame
Baseline to Month 36
Secondary Outcome Measure Information:
Title
Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36
Description
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.
Time Frame
Baseline to Month 36
Title
Change in Renal Function Per Year From Week 3 to Month 36
Description
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.
Time Frame
Week 3 to Month 36
Title
Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36
Description
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.
Time Frame
Baseline to Month 36
Title
Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36
Description
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.
Time Frame
At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2
Title
Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36
Description
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.
Time Frame
Baseline to Month 36
Title
Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36
Time Frame
Baseline to Month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Torres, MD, PhD
Organizational Affiliation
Mayo Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Czerwiec, MD, PhD
Organizational Affiliation
Otsuka Pharmaceutical Development and Commercialization, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Osamu Sato
Organizational Affiliation
Otsuka Pharmaceutical Corporation, Ltd. Japan
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5114
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Coastal Nephrology Associates Research Center, LLC
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Renal Associates of Baton Rough, L.L.C.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
John Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Tufts- New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Medical Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Nephrology Associates of Westchester
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina, UNC, Kidney Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Kidney and Hypertension Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University Hospitals of Cleveland/Case
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Northwest Renal Clinic, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Charleston Nephrology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-1371
Country
United States
Facility Name
University of Virginia, Nephrology Clinical Research Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Instituto de Nefrología, Nefrology SA
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay
City
Buenos Aires
ZIP/Postal Code
1602
Country
Argentina
Facility Name
Hosptial Universitario Austral
City
Buenos Aires
ZIP/Postal Code
B1664INZ
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000IUP
Country
Argentina
Facility Name
Hospital Privado-Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEA
Country
Argentina
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Queen Elizebeth Hospital
City
Adelaide
ZIP/Postal Code
5011
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
ZIP/Postal Code
3050
Country
Australia
Facility Name
Melbourne Renal Research Group
City
Melbourne
ZIP/Postal Code
3121
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6054
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
ZIP/Postal Code
2145
Country
Australia
Facility Name
Ucl-St Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Queen Elizabeth II Health Science Center, Division of Nephrology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H1v8
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Name
Hospital du Sacre- Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Herlev Amtssygehus
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU-Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU - Hôpital Clémenceau
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon Cedex 3
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Facility Name
CHU - Hôpital Nord
City
Saint-Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Hopital Rangueil
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Nephrologische Gemeinschaftspraxis/Dialysezentrum
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Klinik für Nieren- und Hochdruckkrankheiten
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
78106
Country
Germany
Facility Name
Universitätskliniken Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
UH Erlangen/Nürnberg
City
Nuernberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Università Vita e Salute, Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Policlinico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRCCS Fondazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fujita Health University Hospital
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
4701192
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
608648
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
2591193
Country
Japan
Facility Name
Toranomon Hospital Kajigaya
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
2288555
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-City
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Facility Name
Shuwa General Hospital
City
Kasukabe
State/Province
Saitama
ZIP/Postal Code
3440035
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
3508500
Country
Japan
Facility Name
Hamamatsu University School of Medicine, University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
4313192
Country
Japan
Facility Name
Jichi Medical School Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan
Facility Name
Tokyo Medical & Dental University Hospital, Faculty of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138519
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138603
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738606
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
1058471
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
1818611
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1628666
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
National Hospital Organization Chiba-East Hospital
City
Chiba
ZIP/Postal Code
2608712
Country
Japan
Facility Name
Kyusyu University Hospital
City
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
9601295
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Kumamoto Univeristy Hospital
City
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
6068507
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
9518520
Country
Japan
Facility Name
Ohno Memorial Hospital
City
Osaka
ZIP/Postal Code
5500015
Country
Japan
Facility Name
Saitama Medical Center Jichi Medical University
City
Saitama
ZIP/Postal Code
3308503
Country
Japan
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
UMCG Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Oddział Nefrologiczny Stacja Dializ
City
Ciechanow
ZIP/Postal Code
06-400
Country
Poland
Facility Name
Akademickie Centrum Kliniczne AMG
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
SOP ZOZ Uniwersytecki Szpital Kliniczny
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Klinika Chorób Wewnętrznych i Nefrologii
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Międzyleski Szpital Specjalistyczny w Warszawie
City
Warsaw
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
03-401
Country
Poland
Facility Name
Szpital Praski, Samodzielny Publiczny ZOZ
City
Warszawa
ZIP/Postal Code
03-401
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im J Mikulicza Radeckiego
City
Wroclaw
ZIP/Postal Code
50-417
Country
Poland
Facility Name
Spitalul Clinic de Nefrologie Dr. Carol Davila
City
Bucharest
ZIP/Postal Code
10731
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Spitalul Clinic "C.I.Parhon"
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Kemerovo Medical Academy, Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650061
Country
Russian Federation
Facility Name
City Clinical Hospital #52
City
Moscow
ZIP/Postal Code
123060
Country
Russian Federation
Facility Name
City Mariinskiy Hospital
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St.-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Oueen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Sussex Renal Unit Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Uhcw Mhs Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Infirmary
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Royal Free and University College Medical School
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5-9RS
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
ZIP/Postal Code
SW170RE
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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14502283
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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.
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Citation
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Learn more about this trial

Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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