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Polycystic Kidney, Autosomal DominantPhase 3NCT02251275

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

A Phase 3 study testing Tolvaptan in people with Polycystic Kidney, Autosomal Dominant, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 210 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polycystic Kidney, Autosomal Dominant
What is being tested?
Tolvaptan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,803 participants
Where
210 sitesin 20 countries
Study dates
17 Oct 2014to 9 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

210 sites in 20 countries.

210 sites in 20 countries

United States81 sites

  • Study site

    Akron, Ohio, 44302

  • Study site

    Arlington, Texas, 76015

  • Study site

    Arlington, Virginia, 22207

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21224

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Bethlehem, Pennsylvania, 18017

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Buffalo, New York, 14219

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45206

  • Study site

    Cincinnati, Ohio, 45229

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Columbia, South Carolina, 29203

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Denver, Colorado, 80204

  • Study site

    Denver, Colorado, 80210

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Eatontown, New Jersey, 07724

  • Study site

    Fargo, North Dakota, 58102

  • Study site

    Grand Rapids, Michigan, 49506

  • Study site

    Greenbelt, Maryland, 20770

  • Study site

    Houston, Texas, 77004

  • Study site

    Houston, Texas, 77030

  • Study site

    Hudson, Florida, 34667

  • Study site

    Huntsville, Alabama, 35805

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kalamazoo, Michigan, 49007

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Knoxville, Tennessee, 37923

  • Study site

    La Jolla, California, 92037

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Laurelton, New York, 11413

  • Study site

    Los Angeles, California, 90022

  • Study site

    Los Angeles, California, 90095

  • Study site

    McAllen, Texas, 78503

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Miami, Florida, 33150

  • Study site

    Mineola, New York, 11501

  • Study site

    Mobile, Alabama, 36617

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10032

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Ocala, Florida, 34471

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Phoenix, Arizona, 85381

  • Study site

    Pontiac, Michigan, 48341

  • Study site

    Port Charlotte, Florida, 33952

  • Study site

    Portland, Oregon, 97210

  • Study site

    Reno, Nevada, 89511

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Roseville, Michigan, 48066

  • Study site

    San Francisco, California, 94143

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stanford, California, 94305

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tempe, Arizona, 85284

  • Study site

    Tucson, Arizona, 85745

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

United Kingdom21 sites

  • Study site

    Belfast, County Antrim, BT9 7AB

  • Study site

    Birmingham, West Midlands, B15 2GW

  • Study site

    Brighton, East Sussex, BN2 5BE

  • Study site

    Coventry, Warwickshire, CV2 2DX

  • Study site

    Edinburgh, Lothian Region, EH16 4SA

  • Study site

    Exeter, Devon, EX2 5DW

  • Study site

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • Study site

    Inverness, Highland Region, IV2 3UJ

  • Study site

    Leicester, Leicestershire, LE5 4PW

  • Study site

    Liverpool, Norfolk, L7 8XP

  • Study site

    London, Greater London, NW3 2QG

  • Study site

    London, Greater London, SE5 9RS

  • Study site

    London, Greater London, SW17 0QT

  • Study site

    Manchester, Greater Manchester, M13 9WL

  • Study site

    Middlesbrough, TS4 3BW

  • Study site

    Newcastle upon Tyne, Tyne & Wear, NE7 7DN

  • Study site

    Salford, Greater Manchester, M6 8HD

  • Study site

    Sheffield, South Yorkshire, S5 7AU

  • Study site

    Stevenage, Hertfordshire, SG1 4AB

  • Study site

    Stoke-on-Trent, Staffordshire, ST4 7LN

  • Study site

    Swansea, SA6 6NL

Other trials in United Kingdom

Australia11 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Launceston, Tasmania, 7250

  • Study site

    New Lambton Heights, New South Wales, 2305

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Reservoir, Victoria, 3073

  • Study site

    Richmond, Victoria, 3121

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Westmead, New South Wales, 2145

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Argentina10 sites

  • Study site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS

  • Study site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425APQ

  • Study site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1429BWN

  • Study site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

  • Study site

    Córdoba, X5000JHQ

  • Study site

    Córdoba, X5016KEH

  • Study site

    Córdoba, X5166BPW

  • Study site

    Junín, Buenos Aires, 6000

  • Study site

    Pergamino, Buenos Aires, B2700CPM

  • Study site

    Pilar, Buenos Aires, B1629ODT

Other trials in Argentina

Poland10 sites

  • Study site

    Ciechanów, 06-400

  • Study site

    Gdansk, 80-952

  • Study site

    Golub-Dobrzyń, 87-400

  • Study site

    Krakow, 31-559

  • Study site

    Lodz, 92-213

  • Study site

    Lodz, 93-347

  • Study site

    Lublin, 20-954

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 04-749

  • Study site

    Wroclaw, 50-556

Other trials in Poland

Czechia9 sites

  • Study site

    Brno, 625 00

  • Study site

    České Budějovice, 370 87

  • Study site

    Hradec Králové, 500 05

  • Study site

    Jihlava, 586 01

  • Study site

    Jilemnice, 51401

  • Study site

    Liberec, 460 63

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 128 08

  • Study site

    Prague, 140 21

Other trials in Czechia

Belgium8 sites

  • Study site

    Aalst, 9300

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1200

  • Study site

    Edegem, 2650

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Germany8 sites

  • Study site

    Berlin, 10117

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40210

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Munich, Bavaria, 81675

  • Study site

    Nuremberg, Bavaria, 90471

  • Study site

    Wiesbaden, Hesse, 65191

Other trials in Germany

Italy8 sites

  • Study site

    Bari, 70124

  • Study site

    Lecco, 23900

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Modena, 41124

  • Study site

    Montichiari, Brescia, 25018

  • Study site

    Naples, 80138

  • Study site

    Pavia, 27100

Other trials in Italy

Canada6 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 3J5

  • Study site

    Scarborough Village, Ontario, M1H 3G4

  • Study site

    Toronto, Ontario, M4C 5T2

  • Study site

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Israel6 sites

  • Study site

    Ashkelon, 78278

  • Study site

    Jerusalem, 9112001

  • Study site

    Nahariya, 2210001

  • Study site

    Petah Tikva, 491004

  • Study site

    Ramat Gan, 52621

  • Study site

    Tel Aviv, 6423906

Other trials in Israel

Russia5 sites

  • Study site

    Kemerovo, 650002

  • Study site

    Krasnoyarsk, 660062

  • Study site

    Saint Petersburg, 19401344

  • Study site

    Saint Petersburg, 197022

  • Study site

    Yaroslavl, 150062

Other trials in Russia

Spain5 sites

  • Study site

    Barcelona, 08907

  • Study site

    Ciudad Real, 13005

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Valencia, 46017

Other trials in Spain

Sweden5 sites

  • Study site

    Gothenburg, 413 45

  • Study site

    Linköping, 58185

  • Study site

    Stockholm, 14186

  • Study site

    Stockholm, 17176

  • Study site

    Uppsala, 75185

Other trials in Sweden

Romania4 sites

  • Study site

    Bucharest, 010731

  • Study site

    Bucharest, 011794

  • Study site

    Bucharest, 022328

  • Study site

    Oradea, 410469

Other trials in Romania

Denmark3 sites

  • Study site

    Aalborg, 9100

  • Study site

    Aarhus N, 8200

  • Study site

    Holstebro, 7500

Other trials in Denmark

Hungary3 sites

  • Study site

    Budapest, 1032

  • Study site

    Pécs, 7623

  • Study site

    Szeged, 6720

Other trials in Hungary

Netherlands3 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Groningen, 9713 GZ

  • Study site

    Nijmegen, 6525 GA

Other trials in Netherlands

South Africa3 sites

  • Study site

    Cape Town, Western Cape, 7925

  • Study site

    Durban, KwaZulu-Natal, 4001

  • Study site

    Pretoria, Gauteng, 0002

Other trials in South Africa

Norway1 site

  • Study site

    Bergen, 5021

Other trials in Norway

About this study

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

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).

Read the 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).

Being tested
Tolvaptan
Keywords
ADPKD
Medical subject headings
Polycystic Kidney, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TolvaptanDrug

    Also called OPC-41061

    Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later

Study groups in NCT02251275
Study groupRoleWhat they receive
TolvaptanExperimentalTolvaptan 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.
Receives: Drug: Tolvaptan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2014 (estimated)
  2. Study start17 Oct 2014
  3. Primary completion9 Nov 2018
  4. Study completion9 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,803 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02251275
Sponsor's protocol ID
156-13-211
Status last verified
Nov 2019
First submitted
25 Sep 2014
Last updated
27 Nov 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies. Kidney Med. 2023 Apr 14;5(6):100639. doi: 10.1016/j.xkme.2023.100639. eCollection 2023 Jun.

    PubMed 37250503

  • Alpers DH, Lewis JH, Hunt CM, Freston JW, Torres VE, Li H, Wang W, Hoke ME, Roth SE, Westcott-Baker L, Estilo A. Clinical Pattern of Tolvaptan-Associated Liver Injury in Trial Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD): An Analysis of Pivotal Clinical Trials. Am J Kidney Dis. 2023 Mar;81(3):281-293.e1. doi: 10.1053/j.ajkd.2022.08.012. Epub 2022 Sep 30.

    PubMed 36191725

  • 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.

    PubMed 33376102

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolvaptan in people with Polycystic Kidney, Autosomal Dominant, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 210 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, United Kingdom, Australia, Argentina, Poland and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02251275, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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