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Tolvaptan Extension Study in Participants With ADPKD

NCT ID: NCT01214421

Last Updated: 2021-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1083 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-26

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tolvaptan

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.

Group Type EXPERIMENTAL

Tolvaptan

Intervention Type DRUG

Tablets of 15 or 30 mg

Interventions

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Tolvaptan

Tablets of 15 or 30 mg

Intervention Type DRUG

Other Intervention Names

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OPC-41061 Jinarc

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

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Otsuka Investigational Site

Mobile, Alabama, United States

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Peoria, Arizona, United States

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Tempe, Arizona, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Jacksonville, Florida, United States

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Port Charlotte, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Voorhees Township, New Jersey, United States

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Buffalo, New York, United States

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Hawthorne, New York, United States

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New York, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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McAllen, Texas, United States

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Charlottesville, Virginia, United States

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C.a.b.a., Buenos Aires, Argentina

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Pilar, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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St Leonards, New South Wales, Australia

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Westmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Parkville, Victoria, Australia

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Perth, Western Australia, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Halifax, Nova Scotia, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Caen, , France

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Lyon, , France

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Paris, , France

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Reims, , France

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Saint-Etienne, , France

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Toulouse, , France

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Dresden, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Heidelberg, , Germany

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Nuremberg, , Germany

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Bergamo, , Italy

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Milan, , Italy

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Modena, , Italy

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Napoli, , Italy

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Pavia, , Italy

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Amsterdam, , Netherlands

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Groningen, , Netherlands

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Ciechanów, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Iași, , Romania

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Kemerovo, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Brighton, , United Kingdom

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Coventry, , United Kingdom

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Edinburgh, , United Kingdom

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Inverness, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Argentina Australia Belgium Canada France Germany Italy Netherlands Poland Romania Russia United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37349694 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37250503 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36191725 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31014270 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24470398 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21757630 (View on PubMed)

Other Identifiers

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2010-018401-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

156-08-271

Identifier Type: -

Identifier Source: org_study_id