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Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Primary Purpose

Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolvaptan (OPC-41061)
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 Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66)
  • Tolvaptan naïve
  • Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history

Exclusion Criteria:

  • Women of childbearing potential 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 Investigational medicinal product (IMP)
  • Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP
  • Need for chronic diuretic use
  • Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
  • Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
  • Contraindications to required trial assessments
  • Medical history or medical findings inconsistent with safety or compliance with trial assessments

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tolvaptan

Placebo

Arm Description

Tolvaptan (OPC-41061)

Placebo

Outcomes

Primary Outcome Measures

The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.
The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.

Secondary Outcome Measures

Mean Annualized Slope of eGFR Change
To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula. The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented.

Full Information

First Posted
June 6, 2014
Last Updated
July 13, 2018
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02160145
Brief Title
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Official Title
A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
April 18, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
Detailed Description
The protocol will extend the understanding of the efficacy and safety of tolvaptan treatment in ADPKD patients with late stage 2 to early stage 4 CKD (chronic kidney disease). This trial will compare the efficacy of tolvaptan treatment in reducing the annualized change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial run-in period. The change in eGFR, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula, will provide kidney function data that are complementary to the data demonstrating the benefits previously observed primarily in ADPKD subjects with earlier stages of disease. Also, it will compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in this type of subjects. Finally, it will compare the overall and hepatic safety profile of tolvaptan with placebo and to compare incidence of ADPKD complications (outcomes) during the trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
Keywords
Chronic Kidney Disease, 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
1370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
Tolvaptan (OPC-41061)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tolvaptan (OPC-41061)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Primary Outcome Measure Information:
Title
The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.
Description
The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.
Time Frame
Pretreatment baseline to post-treatment follow-up (up to 61 weeks).
Secondary Outcome Measure Information:
Title
Mean Annualized Slope of eGFR Change
Description
To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula. The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented.
Time Frame
Pretreatment baseline to post-treatment follow-up (up to 61 weeks).
Other Pre-specified Outcome Measures:
Title
Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up
Description
The mean change from baseline in urine osmolality for the double-blind treatment period collection timepoints and post-treatment follow-up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.
Time Frame
Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.
Title
Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up
Description
The mean change from baseline in urine specific gravity for the double-blind treatment period collection timepoints and post-treatment follow up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.
Time Frame
Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66) Tolvaptan naïve Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history Exclusion Criteria: Women of childbearing potential 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 Investigational medicinal product (IMP) Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP Need for chronic diuretic use Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury Contraindications to required trial assessments Medical history or medical findings inconsistent with safety or compliance with trial assessments
Facility Information:
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Birmingham
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Arlington
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Houston
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Houston
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77030
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McAllen
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Bahia Blanca
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Buenos Aires
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Argentina
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Ciudad Autonoma
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Buenos Aires
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Argentina
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Ciudad Autonoma
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Buenos Aires
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Argentina
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Ciudad Autonoma
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Buenos Aires
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Argentina
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Ciudad Autonoma
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Buenos Aires
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C1429BWN
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Argentina
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Ciudad Autonoma
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Buenos Aires
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C1431FWO
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Argentina
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Junin
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Buenos Aires
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6000
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Argentina
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Pergamino
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Buenos Aires
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Argentina
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Pilar
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Buenos Aires
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Argentina
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Sarandi
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Cordoba
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Argentina
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Cordoba
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Argentina
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Camperdown
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2050
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Australia
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Concord
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New South Wales
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2139
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Australia
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New Lambton Heights
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New South Wales
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2305
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Australia
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St. Leonards
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New South Wales
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2065
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Australia
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Westmead
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New South Wales
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2145
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Australia
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Woolloongabba
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Queensland
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4102
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Australia
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Adelaide
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South Australia
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5000
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Australia
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Launceston
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Tasmania
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7250
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Australia
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Parkville
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Victoria
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3050
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Australia
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Reservoir
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Victoria
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3073
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Australia
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Richmond
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Victoria
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3121
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Australia
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Perth
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6000
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Australia
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Aalst
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9300
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Belgium
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Antwerpen
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2650
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Belgium
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Bruxelles
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1090
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Belgium
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Bruxelles
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1200
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Belgium
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Gent
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9000
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Belgium
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Kortrijk
ZIP/Postal Code
8500
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Belgium
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Leuven
ZIP/Postal Code
3000
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Belgium
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Liège
ZIP/Postal Code
400
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Belgium
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Edmonton
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Alberta
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T6G 2B7
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Canada
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St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
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Canada
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Scarborough
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Ontario
ZIP/Postal Code
M1H 3G4
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Canada
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Toronto
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Ontario
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M4C 5T2
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Canada
City
Toronto
State/Province
Ontario
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M5C 2T2
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Canada
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Toronto
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Ontario
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M5G 2N2
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Canada
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Greenfield Park
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Quebec
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J4V 2H1
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Canada
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Montreal
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Quebec
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H3A 1A1
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Canada
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Montréal
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Quebec
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H4J 1C5
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Canada
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Brno
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625 00
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Czechia
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Ceske Budejovice
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370 01
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Czechia
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Hradec Kralove
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500 05
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Czechia
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Jihlava
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586 33
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Czechia
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Jilemnice
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51401
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Czechia
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Liberec
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460 63
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Czechia
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Ostrava
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708 52
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Czechia
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Praha 2
ZIP/Postal Code
128 08
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Czechia
City
Praha 4
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140 21
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Czechia
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Tabor
ZIP/Postal Code
390 03
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Czechia
City
Aalborg
ZIP/Postal Code
9100
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Denmark
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
City
Brest cedex 2
State/Province
Finistere
ZIP/Postal Code
29609
Country
France
City
Bordeaux Cedex
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
City
Toulouse Cedex 9
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
City
Montpellier cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
City
Grenoble cedex 9
State/Province
Isere
ZIP/Postal Code
38043
Country
France
City
Saint-Priest-En-Jarez
State/Province
Loire
ZIP/Postal Code
42055
Country
France
City
Reims Cedex
State/Province
Marne
ZIP/Postal Code
51090
Country
France
City
Vandoeuvre les Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54511
Country
France
City
Lyon Cedex 03
State/Province
Rhone
ZIP/Postal Code
69437
Country
France
City
Pierre-Bénite cedex
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
City
Heidelberg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90471
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Duesseldorf
State/Province
Nordrhein Westfalen
ZIP/Postal Code
40210
Country
Germany
City
Essen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Wiesbaden
State/Province
Nordrhein Westfalen
ZIP/Postal Code
65191
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Petaẖ Tiqwa
ZIP/Postal Code
4941492
Country
Israel
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
City
Tel Aviv
ZIP/Postal Code
34239
Country
Israel
City
Torrette Di Ancona
State/Province
Ancona
ZIP/Postal Code
60126
Country
Italy
City
Montichiari
State/Province
Brescia
ZIP/Postal Code
25018
Country
Italy
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Lecco
ZIP/Postal Code
23900
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Modena
ZIP/Postal Code
41124
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Bergen
ZIP/Postal Code
5021
Country
Norway
City
Oslo
ZIP/Postal Code
0424
Country
Norway
City
Stavanger
ZIP/Postal Code
4068
Country
Norway
City
Ciechanow
ZIP/Postal Code
06-400
Country
Poland
City
Golub Dobrzyn
ZIP/Postal Code
87-400
Country
Poland
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Łódź
ZIP/Postal Code
92-313
Country
Poland
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
City
Bucuresti
ZIP/Postal Code
011794
Country
Romania
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
City
Oradea
ZIP/Postal Code
410649
Country
Romania
City
Krasnoyarsk
ZIP/Postal Code
660062
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
City
Hull
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Stevenage
State/Province
Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
City
Inverness
State/Province
Highland Region
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
City
Edinburgh
State/Province
Lothian Region
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
Middlesbrough
State/Province
North Yorkshire
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31014270
Citation
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.
Results Reference
derived
PubMed Identifier
29105594
Citation
Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Koch G, Ouyang J, McQuade RD, Blais JD, Czerwiec FS, Sergeyeva O; REPRISE Trial Investigators. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. N Engl J Med. 2017 Nov 16;377(20):1930-1942. doi: 10.1056/NEJMoa1710030. Epub 2017 Nov 4.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

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