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Polycystic Kidney Disease, Autosomal DominantPhase 3TEMPO3:4NCT00428948

Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

A Phase 3 study testing Tolvaptan in people with Polycystic Kidney Disease, Autosomal Dominant, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 133 sites in 15 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

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Tolvaptan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,445 participants
Where
133 sitesin 15 countries
Study dates
Jan 2007to Jan 2012
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Legal adult age and able to give Informed Consent.
  • Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.
  • Willingness to comply with reproductive precautions, if female.
  • Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.
  • Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (MRI) at randomization.

Who cannot join

  • Prior exposure to tolvaptan or other experimental PKD therapies.
  • Currently taking medication for purpose of affecting PKD cysts.
  • Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
  • In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives.
  • Patients who are unlikely to adequately comply with study procedures.
  • Patients having contraindications to MRI.
  • Patients taking medications or having any illnesses likely to affect ADPKD outcomes.

Trial locations and contacts

133 sites in 15 countries.

133 sites in 15 countries

United States30 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30308

  • John Hopkins School of Medicine

    Baltimore, Maryland, 21205

  • Renal Associates of Baton Rough, L.L.C.

    Baton Rouge, Louisiana, 70809

  • Tufts- New England Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Erie County Medical Center

    Buffalo, New York, 14215

  • University of North Carolina, UNC, Kidney Center

    Chapel Hill, North Carolina, 27599

  • Charleston Nephrology Associates

    Charleston, South Carolina, 29405

  • University of Virginia, Nephrology Clinical Research Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Kidney and Hypertension Center

    Cincinnati, Ohio, 45220

  • University Hospitals of Cleveland/Case

    Cleveland, Ohio, 44106

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • East Carolina University

    Greenville, North Carolina, 27834

  • Nephrology Associates of Westchester

    Hawthorne, New York, 10532

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Coastal Clinical Research

    Mobile, Alabama, 36608

  • University of South Alabama

    Mobile, Alabama, 36617

  • Nephrology Associates, P.C.

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-1371

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • The Rogosin Institute

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Coastal Nephrology Associates Research Center, LLC

    Port Charlotte, Florida, 33952

  • Northwest Renal Clinic, Inc.

    Portland, Oregon, 97210

  • Apex Research of Riverside

    Riverside, California, 92503

  • Mayo Medical Center

    Rochester, Minnesota, 55905

  • Stanford University Medical Center

    Stanford, California, 94305-5114

Other trials in United States

Japan30 sites

  • Tokyo Medical & Dental University Hospital, Faculty of Medicine

    Bunkyo-ku, Tokyo, 1138519

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 1138603

  • Chiba University Hospital

    Chiba, 2608677

  • National Hospital Organization Chiba-East Hospital

    Chiba, 2608712

  • Kyusyu University Hospital

    Fukuoka, 8128582

  • Fukushima Medical University Hospital

    Fukushima, 9601295

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka, 4313192

  • Hiroshima University Hospital

    Hiroshima, 7348551

  • Tokai University Hospital

    Isehara, Kanagawa, 2591193

  • Shuwa General Hospital

    Kasukabe, Saitama, 3440035

  • Saitama Medical Center

    Kawagoe, Saitama, 3508500

  • Toranomon Hospital Kajigaya

    Kawasaki, Kanagawa, 2138587

  • Kumamoto Univeristy Hospital

    Kumamoto, 8608556

  • Kyoto University Hospital

    Kyoto, 6068507

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Toranomon Hospital

    Minato-ku, Tokyo, 1058470

  • The Jikei University Hospital

    Minato-Ku, Tokyo, 1058471

  • Kyorin University Hospital

    Mitaka, Tokyo, 1818611

  • Niigata University Medical & Dental Hospital

    Niigata, 9518520

  • Osaka City University Hospital

    Osaka, Osaka, 5458586

  • Ohno Memorial Hospital

    Osaka, 5500015

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 2288555

  • Saitama Medical Center Jichi Medical University

    Saitama, 3308503

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 608648

  • Tohoku University Hospital

    Sendai, Miyagi, 9808574

  • Jichi Medical School Hospital

    Shimotsuke, Tochigi, 3290498

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 1628666

  • Osaka University Hospital

    Suita, Osaka, 5650871

  • Teikyo University Hospital

    tabashi City, Tokyo, 1738606

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 4701192

Other trials in Japan

Poland11 sites

  • Oddział Nefrologiczny Stacja Dializ

    Ciechanów, 06-400

  • Akademickie Centrum Kliniczne AMG

    Gdansk, 80-952

  • Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG

    Gdansk, 80-952

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • SOP ZOZ Uniwersytecki Szpital Kliniczny

    Lodz, 90-153

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • Klinika Chorób Wewnętrznych i Nefrologii

    Warsaw, 02-507

  • Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Warsaw, 03-401

  • Szpital Praski, Samodzielny Publiczny ZOZ

    Warsaw, 03-401

  • Międzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, 04-749

  • Akademicki Szpital Kliniczny im J Mikulicza Radeckiego

    Wroclaw, 50-417

Other trials in Poland

United Kingdom11 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Oueen Elizabeth Hospital

    Birmingham, B15 2TH

  • Sussex Renal Unit Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Uhcw Mhs Trust

    Coventry, CV2 2DX

  • Royal Infirmary

    Edinburgh, EH16 4SA

  • Raigmore Hospital

    Inverness, IV2 3UJ

  • Royal Free and University College Medical School

    London, NW3 2PF

  • King's College Hospital

    London, SE5-9RS

  • St. George's Hospital

    London, SW170RE

  • Royal Hallamshire Hospital

    Sheffield, S5 7AU

  • Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

France9 sites

  • CHU-Hopital Pellegrin

    Bordeaux, 33076

  • CHU - Hôpital Clémenceau

    Caen, 14033

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Hôpital de la Conception

    Marseille, 13005

  • CHU - Hôpital Lapeyronie

    Montpellier, 34295

  • Hopital Bichat-Claude Bernard

    Paris, 75018

  • Centre Hospitalier Universitaire

    Reims, 51092

  • CHU - Hôpital Nord

    Saint-Etienne, 42055

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Queen Elizebeth Hospital

    Adelaide, 5011

  • Princess Alexandra Hospital

    Brisbane, 4102

  • Royal Melbourne Hospital

    Melbourne, 3050

  • Melbourne Renal Research Group

    Melbourne, 3121

  • Royal Perth Hospital

    Perth, 6054

  • Royal North Shore Hospital

    Sydney, 2065

  • Westmead Hospital

    Sydney, 2145

Other trials in Australia

Germany6 sites

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 1307

  • Nephrologische Gemeinschaftspraxis/Dialysezentrum

    Düsseldorf, 40210

  • Klinik für Nieren- und Hochdruckkrankheiten

    Essen, 45147

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 78106

  • Universitätskliniken Heidelberg

    Heidelberg, 69120

  • UH Erlangen/Nürnberg

    Nuremberg, 90471

Other trials in Germany

Argentina5 sites

  • Instituto de Nefrología, Nefrology SA

    Buenos Aires, 1425

  • Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay

    Buenos Aires, 1602

  • Hosptial Universitario Austral

    Buenos Aires, B1664INZ

  • Sanatorio Allende

    Córdoba, X5000IUP

  • Hospital Privado-Centro Medico de Cordoba

    Córdoba, X5016KEA

Other trials in Argentina

Italy5 sites

  • Ospedali Riuniti di Bergamo

    Bergamo, 24128

  • Università Vita e Salute, Ospedale San Raffaele

    Milan, 20132

  • Policlinico di Modena

    Modena, 41100

  • Policlinico

    Naples, 80131

  • IRCCS Fondazione Salvatore Maugeri

    Pavia, 27100

Other trials in Italy

Russia5 sites

  • Kemerovo Medical Academy, Regional Clinical Hospital

    Kemerovo, 650061

  • City Clinical Hospital #52

    Moscow, 123060

  • City Mariinskiy Hospital

    Saint Petersburg, 191104

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

Other trials in Russia

Belgium3 sites

  • UZ Brussel

    Brussels, 1090

  • Ucl-St Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Canada3 sites

  • Queen Elizabeth II Health Science Center, Division of Nephrology

    Halifax, Nova Scotia, B3H1v8

  • Royal Victoria Hospital

    Montreal, Quebec, H3A1A1

  • Hospital du Sacre- Coeur de Montreal

    Montreal, Quebec, H4J1C5

Other trials in Canada

Romania3 sites

  • Spitalul Clinic de Nefrologie Dr. Carol Davila

    Bucharest, 10731

  • Institutul Clinic Fundeni

    Bucharest, 22328

  • Spitalul Clinic "C.I.Parhon"

    Iași, 700503

Other trials in Romania

Denmark2 sites

  • Herlev Amtssygehus

    Herlev, 2730

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Netherlands2 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • UMCG Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

Read the detailed description

This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other important consequences of ADPKD.

During the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and 90/30 mg orally upon awakening and approximately 9 hours later. As soon as a subject could not tolerate a given dose, the titration phase was over and the maintenance phase began at the dose level tolerated. The maintenance phase lasted to Month 36. Subjects were able to titrate down at any point during the study. Subjects were able to titrate up during the maintenance phase with Medical Monitor approval.

Being tested
Tolvaptan, Placebo
Keywords
ADPKD, Polycystic, kidney, ADPKD (Autosomal Dominant Polycystic Kidney Disease)
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, OPC-156

    Tolvaptan was supplied as tablets.

  • PlaceboDrug

    Placebo was supplied as tablets.

Study groups in NCT00428948
Study groupRoleWhat they receive
TolvaptanExperimentalParticipants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
Receives: Drug: Tolvaptan
PlaceboPlacebo comparatorParticipants received placebo (upon awakening and 9 hours later) orally for 36 months.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36

    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, blinded radiologists used proprietary software to measure the volume of both kidneys.

    Measured: Baseline to Month 36

Secondary outcomes (6)

  1. Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36

    These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis. Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD. The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have > 139 mmHg systolic blood pressure [BP], > 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline. Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol). Categories included normal (< 2.8 female or < 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (> 28 female or > 20 male.

    Measured: Baseline to Month 36

  2. Change in Renal Function Per Year From Week 3 to Month 36

    Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine. The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL). The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.

    Measured: Week 3 to Month 36

  3. Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36

    For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason. The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.

    Measured: Baseline to Month 36

  4. Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36

    Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives [eg, tricyclic antidepressants]) or surgical therapy for pain. In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain. A negative change score indicates less pain. AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.

    Measured: At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2

  5. Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36

    A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP [sBP] > 129 mmHg and/or diastolic BP [dBP] > 84 mmHg), (2) hypertensive (sBP > 139 mmHg and/or dBP > 89 mmHg), or (3) requiring antihypertensive therapy.

    Measured: Baseline to Month 36

  6. Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36

    Measured: Baseline to Month 36

Timeline

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

  1. First posted30 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
1,445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00428948
Sponsor's protocol ID
156-04-251
Other IDs
2006-002768-24
Acronym
TEMPO3:4
Status last verified
May 2017
First submitted
26 Jan 2007
Last updated
2 Jul 2017
Data monitoring committee
Yes

Publications

  • Gattone VH 2nd, Wang X, Harris PC, Torres VE. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nat Med. 2003 Oct;9(10):1323-6. doi: 10.1038/nm935. Epub 2003 Sep 21.

    PubMed 14502283

  • Torres VE, Wang X, Qian Q, Somlo S, Harris PC, Gattone VH 2nd. Effective treatment of an orthologous model of autosomal dominant polycystic kidney disease. Nat Med. 2004 Apr;10(4):363-4. doi: 10.1038/nm1004. Epub 2004 Feb 29.

    PubMed 14991049

  • Torres VE, Meijer E, Bae KT, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang JJ, Czerwiec FS. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study. Am J Kidney Dis. 2011 May;57(5):692-9. doi: 10.1053/j.ajkd.2010.11.029. Epub 2011 Feb 17.

    PubMed 21333426

  • Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.

    PubMed 23121377

  • Watkins PB, Lewis JH, Kaplowitz N, Alpers DH, Blais JD, Smotzer DM, Krasa H, Ouyang J, Torres VE, Czerwiec FS, Zimmer CA. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Saf. 2015 Nov;38(11):1103-13. doi: 10.1007/s40264-015-0327-3.

    PubMed 26188764

  • Kher A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257-8. doi: 10.1056/NEJMc1300762. No abstract available.

    PubMed 23534570

  • Spital A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257. doi: 10.1056/NEJMc1300762. No abstract available.

    PubMed 23534569

  • Torres VE, Gansevoort RT, Czerwiec FS. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1259. doi: 10.1056/NEJMc1300762. No abstract available.

    PubMed 23534568

  • Jouret F, Krzesinski JM. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258-9. doi: 10.1056/NEJMc1300762. No abstract available.

    PubMed 23534572

  • Sexton DJ. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258. doi: 10.1056/NEJMc1300762. No abstract available.

    PubMed 23534571

  • 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

  • Ivaturi V, Gobburu J, Leslie B, Wang X, Jadhav P. Urine Osmolality Is a Potential Marker of Longer-Term Efficacy of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis. Kidney360. 2024 Jul 1;5(7):996-1001. doi: 10.34067/KID.0000000000000485. Epub 2024 Jun 10.

    PubMed 38857379

  • Mochizuki T, Matsukawa M, Tanaka T, Jiang H. Initial eGFR Changes Predict Response to Tolvaptan in ADPKD. Kidney360. 2024 Apr 1;5(4):522-528. doi: 10.34067/KID.0000000000000404. Epub 2024 Feb 28.

    PubMed 38414126

  • Gobburu J, Ivaturi V, Wang X, Shoaf SE, Jadhav P, Perrone RD. Comparing Effects of Tolvaptan and Instruction to Increase Water Consumption in ADPKD: Post Hoc Analysis of TEMPO 3:4. Kidney360. 2023 Dec 1;4(12):1702-1707. doi: 10.34067/KID.0000000000000302. Epub 2023 Nov 21.

    PubMed 37986188

  • Lioudis M, Zhou X, Davenport E, Nunna S, Krasa HB, Oberdhan D, Fernandes AW. Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis. BMC Nephrol. 2023 Jun 22;24(1):182. doi: 10.1186/s12882-023-03247-6.

    PubMed 37349694

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolvaptan in people with Polycystic Kidney Disease, Autosomal Dominant, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 133 sites in 15 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 5 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, Japan, Poland, United Kingdom, France and 10 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 2 Jul 2017). 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?

Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36 (time frame: Baseline to Month 36). 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 NCT00428948, which also lists 22 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 2 Jul 2017.

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