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Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

Primary Purpose

Polycystic Kidney, Autosomal Dominant

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolvaptan
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, Autosomal Dominant focused on measuring ADPKD

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female participants ≥ 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. Participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial.
  • eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m^2 may be enrolled with medical monitor approval.

Exclusion Criteria:

  • Need for chronic diuretic use
  • Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease
  • 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 result prior to receiving IMP.
  • Participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging [MRI] are not a limitation).
  • Participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tolvaptan

Arm Description

Tolvaptan was self-administered orally as split-dose regimens. The dose regimens used in this trial were 15/15 milligram (mg), 30/15 mg, 45/15 mg, 60/30 mg, or 90/30 mg. Starting doses were dependent upon the participant's previous trial as follows: Trial 156-13-210: initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability. Trial 156-08-271: retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211. Other Trials (156-04-251 and 156-09-290): initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.

Outcomes

Primary Outcome Measures

Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2014
Last Updated
November 7, 2019
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02251275
Brief Title
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Official Title
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2014 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
Detailed Description
This was a Phase 3b trial to evaluate and describe the long term safety of tolvaptan treatment in ADPKD participants with chronic kidney disease (CKD). Eligible participants could enroll into Trial 156-13-211 after completing the follow-up visit(s) of their previous trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290). Renal function was assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1803 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
Tolvaptan was self-administered orally as split-dose regimens. The dose regimens used in this trial were 15/15 milligram (mg), 30/15 mg, 45/15 mg, 60/30 mg, or 90/30 mg. Starting doses were dependent upon the participant's previous trial as follows: Trial 156-13-210: initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability. Trial 156-08-271: retained the last dose level of tolvaptan received in the trial (45/15 mg, 60/30 mg, or 90/30 mg) and started at that same dose in Trial 156-13-211. Other Trials (156-04-251 and 156-09-290): initiated on tolvaptan at a split-dose of 45/15 mg with upward titration every 3 to 4 days to 60/30 mg or 90/30 mg per day according to tolerability.
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
OPC-41061
Intervention Description
Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Primary Outcome Measure Information:
Title
Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.
Time Frame
Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants ≥ 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. Participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial. eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m^2 may be enrolled with medical monitor approval. Exclusion Criteria: Need for chronic diuretic use Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease 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 result prior to receiving IMP. Participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging [MRI] are not a limitation). Participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance
Facility Information:
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Milano
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Pavia
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Amsterdam
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Groningen
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Nijmegen
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Norway
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Gdansk
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Poland
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87-400
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Poland
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
City
Lodz
ZIP/Postal Code
93-347
Country
Poland
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Bucuresti
ZIP/Postal Code
010731
Country
Romania
City
Bucuresti
ZIP/Postal Code
011794
Country
Romania
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
City
Oradea
ZIP/Postal Code
410469
Country
Romania
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660062
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
19401344
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
197022
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
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
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Belfast
State/Province
County Antrim
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
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
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0QT
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
Norfolk
ZIP/Postal Code
L7 8XP
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 7LN
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
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2GW
Country
United Kingdom
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
Citations:
PubMed Identifier
33376102
Citation
Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Lee J, Hoke ME, Estilo A, Sergeyeva O. Multicenter Study of Long-Term Safety of Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2020 Dec 31;16(1):48-58. doi: 10.2215/CJN.10250620. Epub 2020 Dec 29.
Results Reference
derived

Learn more about this trial

Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

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