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Tolvaptan Extension Study in Participants With ADPKD | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Tolvaptan Extension Study in Participants With ADPKD

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)

NCT01214421•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+7 more criteria

Locations (97)

Otsuka Investigational Site

Mobile, Alabama, United States

Otsuka Investigational Site

Peoria, Arizona, United States

Otsuka Investigational Site

Tempe, Arizona, United States

Otsuka Investigational Site

Los Angeles, California, United States

Otsuka Investigational Site

Palo Alto, California, United States

Otsuka Investigational Site

San Diego, California, United States

Otsuka Investigational Site

Aurora, Colorado, United States

Otsuka Investigational Site

New Haven, Connecticut, United States

Otsuka Investigational Site

Jacksonville, Florida, United States

Otsuka Investigational Site

Port Charlotte, Florida, United States

Key Dates

Start Date

May 26, 2010

Primary Completion Date

February 29, 2016

Completion Date

February 29, 2016

Last Updated

October 25, 2021

Enrollment

1,083

ACTUAL participants

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

Tolvaptan

DRUG

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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ACTIVE_NOT_RECRUITING

A Possible Founding PKD2 Mutation Associated With Variable Phenotypes of ADPKD in Bergamo Province

NCT06594367

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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ACTIVE_NOT_RECRUITINGPHASE2

Study of Tamibarotene in Patients With ADPKD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tolvaptan Extension Study in Participants With ADPKD

Inclusion Criteria

Exclusion Criteria

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

A Possible Founding PKD2 Mutation Associated With Variable Phenotypes of ADPKD in Bergamo Province

Study of Tamibarotene in Patients With ADPKD

Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)