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Tolvaptan Extension Study in Participants With ADPKD (TEMPO 4/4)

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tolvaptan

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

- Participants who had successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment study, with a confirmed diagnosis of ADPKD from prior studies [either 156-04-251 (NCT00428948) or 156-04-250 (NCT00413777), 156-06-260, 156-09-284 (NCT01336972), 156-09-285 (NCT01210560), and 156-09-290 (NCT01451827)].

Exclusion Criteria:

Participants unable to provide written informed consent.
Participants (men or women) would not adhere to the reproductive precautions as outlined in the Informed Consent Form.
Participants (women only) with a positive urine pregnancy test.
Participants who were pregnant or breast-feeding.
Participants unable to take oral medications.
Participants who had allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine).
Participants with disorders in thirst recognition or an inability to access fluids.
Participants with critical electrolyte imbalances, as determined by the investigator
Participants with or at risk of significant hypovolemia, as determined by investigator.
Participants with significant anemia, as determined by investigator.
Participants with a history of substance abuse (within the last 3 years).
Participants who were taking other experimental (that is, non-marketed) therapies or were participating in another clinical drug or device study; participating in the off-drug follow-up period of another ADPKD trial with tolvaptan was permitted.
Participants unable to complete magnetic resonance imaging (MRI) assessments (for example, participants with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia).
Participants who had taken a vasopressin antagonist (outside of previous participation in a tolvaptan study).
Participants unable to comply with anti-hypertensive or other important medical therapy.
Participants with advanced diabetes.
Participants who were taking medications or had an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting polycystic kidney disease [PKD] cysts).

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tolvaptan

Arm Description

Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 milligrams (mg) in the morning [AM]/15 mg in the evening [PM] titrated to 60 mg [AM]/30 mg [PM], then 90 mg [AM]/30 mg [PM] based on tolerability were given orally twice daily until the last participant originating from prior studies (either 156-04-251 or 156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290) who was eligible for efficacy analysis completed the Month 24.

Outcomes

Primary Outcome Measures

Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)

Total kidney volume is a measure of disease progression in the ADPKD participants. 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, radiologists used proprietary software to measure the volume of both kidneys in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). The percent change in the volume of both kidneys combined was analysed using mixed-effect model repeated measures (MMRM) analysis and reported. This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251, as pre-specified in the protocol.

Secondary Outcome Measures

Change From the Baseline in Estimated Glomerular Filtration Rate (eGFR) as Assessed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)

Estimated Glomerular Filtration Rate (eGFR) according to CKD-EPI is calculated using the CKD-EPI equation, expressed as a single equation, is GFR = 141 × min (serum creatinine [Scr]/κ, 1)α × max(Scr/κ, 1)^-1.209 × 0.993 Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1 in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in eGFR for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). MMRM was used for the analysis. This outcome measure was analyzed only in the participants enrolled from the previous - 156-04-251, as pre-specified in the protocol.

Annualized Slope of Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in Study 156-08-271

Annualized slope of TKV is a measure of renal function and disease progression in ADPKD participants. The annualized slope is calculated as percentage of growth in TKV (measured in mL by MRI) divided by each participant's years of participation for all participants was calculated using MMRM analysis in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing annualized slope of TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251, as pre-specified in the protocol.

Annualized Slope of eGFR (CKD-EPI) for Study 156-04-251 Participants Enrolled in Study 156-08-271

Annualized slope of eGFR (CKD-EPI) is a measure of renal function and disease progression in ADPKD participants. The annualized slope of eGFR (CKD-EPI) (divided by each participant's years of participation) for all participants was calculated using MMRM analysis in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula. This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251, as pre-specified in the protocol.

Annualized TKV Slope for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271

Annualized slope of TKV is a measure of renal function and disease progression in ADPKD participants. The annualized slope is calculated as percentage of growth in TKV (measured in mL by MRI) divided by each participant's years of participation, using MMRM analysis to compare annualized slope of TKV for the participants who received placebo in previous study (156-04-251) to annualized slope of TKV for the same participants who received tolvaptan in this study (156-08-271). This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251 and who received placebo in the previous study, as pre-specified in the protocol.

Annualized Slope of Renal Function (eGFRCKD-EPI) for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271

Annualized slope of eGFR (CKD-EPI) is a measure of renal function and disease progression in ADPKD participants. The annualized slope of eGFR (calculated using CKD-EPI formula) divided by each participant's years of participation, using MMRM analysis to compare annualized slope of eGFR (CKD-EPI) for the participants who received placebo in previous study (156-04-251) to the annualized slope of eGFR (CKD-EPI) for the same participants who received tolvaptan in this study (156-08-271). This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251 who received placebo in previous study and received tolvaptan in this study, as pre-specified in the protocol.

Full Information

NCT ID

NCT01214421

First Posted

September 26, 2010

Last Updated

September 27, 2021

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01214421

Brief Title

Tolvaptan Extension Study in Participants With ADPKD

Acronym

TEMPO 4/4

Official Title

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 26, 2010 (Actual)

Primary Completion Date

February 29, 2016 (Actual)

Study Completion Date

February 29, 2016 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

Kidney Disease, ADPKD, Autosomal Dominant Polycystic Kidney Disease, Adult Polycystic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1083 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tolvaptan

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tolvaptan

Other Intervention Name(s)

OPC-41061, Jinarc

Intervention Description

Tablets of 15 or 30 mg

Primary Outcome Measure Information:

Title

Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)

Description

Time Frame

Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271)

Secondary Outcome Measure Information:

Title

Description

Time Frame

Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271)

Title

Annualized Slope of Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in Study 156-08-271

Description

Time Frame

Study Baseline (Prior to Day 1 in Study 156-08-271) to Month 24 in this study (Study 156-08-271)

Title

Annualized Slope of eGFR (CKD-EPI) for Study 156-04-251 Participants Enrolled in Study 156-08-271

Description

Time Frame

Study Baseline (Prior to Day 1 in Study 156-08-271) to Month 24 (Study 156-08-271)

Title

Annualized TKV Slope for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271

Description

Annualized slope of TKV is a measure of renal function and disease progression in ADPKD participants. The annualized slope is calculated as percentage of growth in TKV (measured in mL by MRI) divided by each participant's years of participation, using MMRM analysis to compare annualized slope of TKV for the participants who received placebo in previous study (156-04-251) to annualized slope of TKV for the same participants who received tolvaptan in this study (156-08-271). This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251 and who received placebo in the previous study, as pre-specified in the protocol.

Time Frame

Tolvaptan, Delayed Treated: Baseline to Month 24 in Study 156-08-271; Placebo: Baseline to Month 36 in Study 156-04-251

Title

Annualized Slope of Renal Function (eGFRCKD-EPI) for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271

Description

Time Frame

Tolvaptan, Delayed Treated: Baseline to Month 24 in Study 156-08-271; Placebo: Baseline to Month 36 in Study 156-04-251

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Participants who had successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment study, with a confirmed diagnosis of ADPKD from prior studies [either 156-04-251 (NCT00428948) or 156-04-250 (NCT00413777), 156-06-260, 156-09-284 (NCT01336972), 156-09-285 (NCT01210560), and 156-09-290 (NCT01451827)]. Exclusion Criteria: Participants unable to provide written informed consent. Participants (men or women) would not adhere to the reproductive precautions as outlined in the Informed Consent Form. Participants (women only) with a positive urine pregnancy test. Participants who were pregnant or breast-feeding. Participants unable to take oral medications. Participants who had allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine). Participants with disorders in thirst recognition or an inability to access fluids. Participants with critical electrolyte imbalances, as determined by the investigator Participants with or at risk of significant hypovolemia, as determined by investigator. Participants with significant anemia, as determined by investigator. Participants with a history of substance abuse (within the last 3 years). Participants who were taking other experimental (that is, non-marketed) therapies or were participating in another clinical drug or device study; participating in the off-drug follow-up period of another ADPKD trial with tolvaptan was permitted. Participants unable to complete magnetic resonance imaging (MRI) assessments (for example, participants with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia). Participants who had taken a vasopressin antagonist (outside of previous participation in a tolvaptan study). Participants unable to comply with anti-hypertensive or other important medical therapy. Participants with advanced diabetes. Participants who were taking medications or had an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting polycystic kidney disease [PKD] cysts).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Otsuka Pharmaceutical Development & Commercialization, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Otsuka Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36617

Country

United States

Facility Name

Otsuka Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Otsuka Investigational Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85284

Country

United States

Facility Name

Otsuka Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Otsuka Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Otsuka Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Otsuka Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Otsuka Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Otsuka Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Otsuka Investigational Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Otsuka Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Otsuka Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Otsuka Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Otsuka Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Otsuka Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Otsuka Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Otsuka Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Otsuka Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Otsuka Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Otsuka Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Otsuka Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Otsuka Investigational Site

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Otsuka Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Otsuka Investigational Site

City

Hawthorne

State/Province

New York

ZIP/Postal Code

10532

Country

United States

Facility Name

Otsuka Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Otsuka Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Otsuka Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Otsuka Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

Facility Name

Otsuka Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Otsuka Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Otsuka Investigational Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

Otsuka Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Otsuka Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Otsuka Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Otsuka Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Otsuka Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76015

Country

United States

Facility Name

Otsuka Investigational Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

Otsuka Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Otsuka Investigational Site

City

C.a.b.a.

State/Province

Buenos Aires

ZIP/Postal Code

C1429BWN

Country

Argentina

Facility Name

Otsuka Investigational Site

City

Pilar

State/Province

Buenos Aires

ZIP/Postal Code

B1629ODT

Country

Argentina

Facility Name

Otsuka Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1425APQ

Country

Argentina

Facility Name

Otsuka Investigational Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Otsuka Investigational Site

City

Córdoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Otsuka Investigational Site

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Otsuka Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Otsuka Investigational Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Otsuka Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Otsuka Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Otsuka Investigational Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Facility Name

Otsuka Investigational Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Otsuka Investigational Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Otsuka Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Otsuka Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V8

Country

Canada

Facility Name

Otsuka Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A1A1

Country

Canada

Facility Name

Otsuka Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J1C5

Country

Canada

Facility Name

Otsuka Investigational Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Otsuka Investigational Site

City

Caen Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

Otsuka Investigational Site

City

Lyon Cedex 3

ZIP/Postal Code

69437

Country

France

Facility Name

Otsuka Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Otsuka Investigational Site

City

Reims Cedex

ZIP/Postal Code

51092

Country

France

Facility Name

Otsuka Investigational Site

City

Saint-Etienne Cedex 2

ZIP/Postal Code

42055

Country

France

Facility Name

Otsuka Investigational Site

City

Toulouse Cedex 09

ZIP/Postal Code

31059

Country

France

Facility Name

Otsuka Investigational Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Otsuka Investigational Site

City

Dusseldorf

ZIP/Postal Code

40210

Country

Germany

Facility Name

Otsuka Investigational Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Otsuka Investigational Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Otsuka Investigational Site

City

Nurnberg

ZIP/Postal Code

90471

Country

Germany

Facility Name

Otsuka Investigational Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Otsuka Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Otsuka Investigational Site

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

Otsuka Investigational Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Otsuka Investigational Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Otsuka Investigational Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Otsuka Investigational Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Otsuka Investigational Site

City

Ciechanów

ZIP/Postal Code

06-400

Country

Poland

Facility Name

Otsuka Investigational Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Otsuka Investigational Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Otsuka Investigational Site

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Otsuka Investigational Site

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Otsuka Investigational Site

City

Warszawa

ZIP/Postal Code

04-749

Country

Poland

Facility Name

Otsuka Investigational Site

City

Wrocław

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Otsuka Investigational Site

City

Bucuresti

ZIP/Postal Code

010731

Country

Romania

Facility Name

Otsuka Investigational Site

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Otsuka Investigational Site

City

Iasi

ZIP/Postal Code

700504

Country

Romania

Facility Name

Otsuka Investigational Site

City

Kemerovo

ZIP/Postal Code

650029

Country

Russian Federation

Facility Name

Otsuka Investigational Site

City

St. Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

Otsuka Investigational Site

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

Otsuka Investigational Site

City

Belfast

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

Brighton

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

Inverness

ZIP/Postal Code

IV2 3UJ

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Otsuka Investigational Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Otsuka Investigational Site

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 the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing URL

https://clinical-trials.otsuka.com

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

24470398

Citation

Thimmappa ND, Blumenfeld JD, Cerilles MA, Dunning A, Donahue SL, Bobb WO, Zhang HL, Prince MR. Cisterna chyli in autosomal dominant polycystic kidney disease. J Magn Reson Imaging. 2015 Jan;41(1):142-8. doi: 10.1002/jmri.24527. Epub 2014 Jan 27.

Results Reference

derived

PubMed Identifier

21757630

Citation

Blumenfeld JD, Tepler J, Mauer A, Coller B, Bichet DG, Smith B. Tolvaptan inhibition of desmopressin effects on coagulation factors in a patient with decreased von Willebrand factor and polycystic kidney disease. Blood. 2011 Jul 14;118(2):474-6. doi: 10.1182/blood-2011-04-347328. No abstract available.

Results Reference

derived

Learn more about this trial

Tolvaptan Extension Study in Participants With ADPKD

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Tolvaptan Extension Study in Participants With ADPKD (TEMPO 4/4)

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial