AzTrials
AzTrials

Chronic Kidney DiseasePhase 3NCT02160145

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

A Phase 3 study testing Tolvaptan (OPC-41061) in people with Chronic Kidney Disease and Autosomal Dominant Polycystic Kidney Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 230 sites in 22 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 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) Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Tolvaptan (OPC-41061)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,370 participants
Where
230 sitesin 22 countries
Study dates
May 2014to 18 Apr 2017
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

230 sites in 22 countries.

230 sites in 22 countries

United States82 sites

  • Study site

    Akron, Ohio, 44302

  • Study site

    Arlington, Texas, 76015

  • Study site

    Arlington, Virginia, 22205

  • 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

    Baton Rouge, Louisiana, 70808

  • Study site

    Bethlehem, Pennsylvania, 18017

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Buffalo, New York, 14215

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Chapel Hill, North Carolina, 27599-7155

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45206

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbia, South Carolina, 29203

  • Study site

    Columbus, Ohio, 43210

  • 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, 58122

  • Study site

    Grand Forks, North Dakota, 58201

  • Study site

    Greenbelt, Maryland, 20770

  • Study site

    Houston, Texas, 77030-3411

  • 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, 39723

  • Study site

    La Crosse, Wisconsin, 54601

  • Study site

    La Jolla, California, 92037

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Los Angeles, California, 90022

  • Study site

    Los Angeles, California, 90025

  • Study site

    McAllen, Texas, 78503

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Miami, Florida, 33150

  • Study site

    Mineola, New York, 11501

  • Study site

    Minneapolis, Minnesota, 55404

  • 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, 10016

  • 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, 98686

  • Study site

    Reno, Nevada, 89511

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Rosedale, New York, 11422

  • Study site

    Roseville, Michigan, 48066

  • Study site

    San Francisco, California, 94143

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    St Louis, Missouri, 63110

  • 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

    Wheaton, Maryland, 20906

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

United Kingdom17 sites

  • 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, Merseyside, L7 8XP

  • Study site

    London, Greater London, NW3 2QG

  • Study site

    Manchester, Greater Manchester, M13 9WL

  • Study site

    Middlesbrough, North Yorkshire, 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 6QG

  • Study site

    Swansea, SA6 6NL

Other trials in United Kingdom

Argentina13 sites

  • Study site

    Bahía Blanca, Buenos Aires, B8000FTD

  • Study site

    Ciudad Autonoma, Buenos Aires, C1093AAS

  • Study site

    Ciudad Autonoma, Buenos Aires, C1119ACN

  • Study site

    Ciudad Autonoma, Buenos Aires, C1425APQ

  • Study site

    Ciudad Autonoma, Buenos Aires, C1429BWN

  • Study site

    Ciudad Autonoma, Buenos Aires, C1431FWO

  • Study site

    Córdoba, X5000JHQ

  • Study site

    Córdoba, X5003DCE

  • Study site

    Córdoba, X5016KEH

  • Study site

    Junín, Buenos Aires, 6000

  • Study site

    Pergamino, Buenos Aires, B2700CPM

  • Study site

    Pilar, Buenos Aires, B1629ODT

  • Study site

    Sarandí, Buenos Aires, B1872EEA

Other trials in Argentina

Australia12 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Concord, New South Wales, 2139

  • 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

Czechia10 sites

  • Study site

    Brno, 625 00

  • Study site

    České Budějovice, 370 01

  • Study site

    Hradec Králové, 500 05

  • Study site

    Jihlava, 586 33

  • Study site

    Jilemnice, 51401

  • Study site

    Liberec, 460 63

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 128 08

  • Study site

    Prague, 140 21

  • Study site

    Tábor, 390 03

Other trials in Czechia

France10 sites

  • Study site

    Bordeaux, Gironde, 33000

  • Study site

    Brest, Finistere, 29609

  • Study site

    Grenoble, Isere, 38043

  • Study site

    Lyon, Rhone, 69437

  • Study site

    Montpellier, Herault, 34295

  • Study site

    Pierre-Bénite, Rhone, 69495

  • Study site

    Reims, Marne, 51090

  • Study site

    Saint-Priest-En-Jarez, Pays de la Loire Region, 42055

  • Study site

    Toulouse, Haute Garonne, 31059

  • Study site

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511

Other trials in France

Italy10 sites

  • Study site

    Bari, 70124

  • Study site

    Bologna, 40138

  • Study site

    Lecco, 23900

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Modena, 41124

  • Study site

    Montichiari, Brescia, 25018

  • Study site

    Naples, 80131

  • Study site

    Pavia, 27100

  • Study site

    Torrette Di Ancona, Ancona, 60126

Other trials in Italy

Canada9 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Scarborough Village, Ontario, M1H 3G4

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study site

    Toronto, Ontario, M4C 5T2

  • Study site

    Toronto, Ontario, M5C 2T2

  • Study site

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Belgium8 sites

  • Study site

    Aalst, 9300

  • Study site

    Antwerp, 2650

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1200

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

  • Study site

    Leuven, 3000

  • Study site

    Liège, 400

Other trials in Belgium

Germany8 sites

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40210

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Munich, Bavaria, 81675

  • Study site

    Nuremberg, Bavaria, 90471

  • Study site

    Wiesbaden, North Rhine-Westphalia, 65191

Other trials in Germany

Poland8 sites

  • Study site

    Ciechanów, 06-400

  • Study site

    Golub-Dobrzyń, 87-400

  • Study site

    Krakow, 31-559

  • Study site

    Lodz, 92-213

  • Study site

    Lodz, 92-313

  • Study site

    Lublin, 20-954

  • Study site

    Warsaw, 04-749

  • Study site

    Wroclaw, 50-556

Other trials in Poland

Spain7 sites

  • Study site

    Ciudad Real, 13005

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Seville, 41009

  • Study site

    Seville, 41071

  • Study site

    Valencia, 46017

Other trials in Spain

Israel6 sites

  • Study site

    Ashkelon, 7830604

  • Study site

    Jerusalem, 9112001

  • Study site

    Nahariya, 22100

  • Study site

    Petah Tikva, 4941492

  • Study site

    Ramat Gan, 52621

  • Study site

    Tel Aviv, 34239

Other trials in Israel

Sweden6 sites

  • Study site

    Gothenburg, 41345

  • Study site

    Linköping, 58185

  • Study site

    Örebro, 70185

  • Study site

    Stockholm, 141 86

  • Study site

    Stockholm, 14186

  • Study site

    Uppsala, 75185

Other trials in Sweden

Denmark5 sites

  • Study site

    Aalborg, 9100

  • Study site

    Aarhus C, 8000

  • Study site

    Holstebro, 7500

  • Study site

    Odense C, 5000

  • Study site

    Viborg, 8800

Other trials in Denmark

Russia4 sites

  • Study site

    Krasnoyarsk, 660062

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 197110

  • Study site

    Yaroslavl, 150062

Other trials in Russia

Hungary3 sites

  • Study site

    Budapest, 1032

  • Study site

    Pécs, 7623

  • Study site

    Szeged, 6720

Other trials in Hungary

Norway3 sites

  • Study site

    Bergen, 5021

  • Study site

    Oslo, 0424

  • Study site

    Stavanger, 4068

Other trials in Norway

Romania3 sites

  • Study site

    Bucharest, 011794

  • Study site

    Bucharest, 022328

  • Study site

    Oradea, 410649

Other trials in Romania

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

Netherlands2 sites

  • Study site

    Groningen, 9713 GZ

  • Study site

    Nijmegen, 6525 GA

Other trials in Netherlands

Puerto Rico1 site

  • Study site

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

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)

Read the 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

Being tested
Tolvaptan (OPC-41061), Placebo
Keywords
Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
Medical subject headings
Renal Insufficiency, Chronic, Polycystic Kidney, Autosomal Dominant

What participants receive

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

  • Tolvaptan (OPC-41061)Drug

    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.

  • PlaceboDrug

    Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later

Study groups in NCT02160145
Study groupRoleWhat they receive
TolvaptanExperimentalTolvaptan (OPC-41061)
Receives: Drug: Tolvaptan (OPC-41061)
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. 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.

    Measured: Pretreatment baseline to post-treatment follow-up (up to 61 weeks).

Secondary outcomes (1)

  1. 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.

    Measured: Pretreatment baseline to post-treatment follow-up (up to 61 weeks).

Timeline

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

  1. First posted10 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion18 Apr 2017
  4. Study completion18 Apr 2017

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160145
Sponsor's protocol ID
156-13-210
Status last verified
Jul 2018
First submitted
6 Jun 2014
Last updated
8 Aug 2018
Data monitoring committee
Yes

Publications

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

    PubMed 39356039

  • 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

  • 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.

    PubMed 31014270

  • 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.

    PubMed 29105594

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolvaptan (OPC-41061) in people with Chronic Kidney Disease and Autosomal Dominant Polycystic Kidney Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 230 sites in 22 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 3 inclusion and 7 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 230 sites in United States, United Kingdom, Argentina, Australia, Czechia and 17 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. Some participants in this study may receive a placebo. 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 8 Aug 2018). 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?

The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. (time frame: Pretreatment baseline to post-treatment follow-up (up to 61 weeks).). 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 NCT02160145, which also lists 5 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 8 Aug 2018.

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