8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT ID: NCT01451827
Last Updated: 2018-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2011-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tolvaptan MR 50 mg
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets ( 8 AM) and 1 placebo IR tablet (4 PM) daily.
Tolvaptan MR
50/80 mg capsules
Placebo
tablet
Tolvaptan MR 80 mg
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Tolvaptan MR
50/80 mg capsules
Placebo
tablet
Tolvaptan IR 60/30 mg
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (8 AM) and 1 tolvaptan IR 30-mg tablet (4 PM) daily.
Tolvaptan IR
60/30 mg capsules
Placebo
tablet
Placebo
Placebo MR capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Placebo
tablet
Interventions
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Tolvaptan MR
50/80 mg capsules
Tolvaptan IR
60/30 mg capsules
Placebo
tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with:
* BMI between 19 and 35 kg/m2
* diagnosis of ADPKD by modified Ravine criteria:
* family history: 3cysts/kidney if by sonography or 5 by CT or MRI
* Without family history: 10 cysts per kidney
* an eGFR \> 45 mL/min/1.73 m2 by the CKD-EPI equation
3. Subjects not planning to become pregnant willing to comply with birth control requirements.
4. Subjects must be in good health as determined by screening tests.
5. Subjects providing informed consent and able to comply with all trial requirements.
Exclusion Criteria
2. Subjects who had an eGFR \< 45 mL/min/1.73 m2 calculated based on the most recent historical creatinine during the last 12 months
3. Subjects with:
* incontinence, overactive bladder, or urinary retention (eg, BPH), meaning subjects with symptoms of frequent nocturia, as determined by medical history or urinary urgency should be carefully evaluated to exclude non-ADPKD GU issues prior to entry.
* liver disease, liver function abnormalities, or serology other than that expected for ADPKD with cystic liver disease at baseline
* a history of renal surgery or cyst drainage within 6 months of randomization
* blood pressure 150/95 mmHg or \< 90/40 mmHg.
* heart rate outside the range of 40 to 90 bpm.
* advanced diabetes with a history of poor control, evidence of significant renal disease renal cancer, single kidney, or recent renal surgery
* other significant medical history that may interfere with the study objectives
* significant abnormalities in serum sodium concentration (\< 135 or \> 145 mEq/L)
* a history of drug and/or alcohol abuse within 2 years prior to screening
* clinically significant allergic reactions to tolvaptan or chemically related structures such as benzazepines (eg, benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine)
4. Subjects having taken an investigational drug within 30 days preceding randomization on Day 0
5. Subjects taking medications or having concomitant illnesses likely to confound endpoint assessments, including taking approved (ie, marketed) therapies for the purpose of affecting PKD cysts such as tolvaptan, somatostatin agonists (ie, octreotide, sandostatin), Rapamune (sirolimus), anti-sense RNA therapies, other vasopressin antagonists (eg, OPC-31260 \[mozavaptan\] and Vaprisol® \[conivaptan\]) or agonists (eg, desmopressin), and cyst reduction surgery
6. Subjects on antihypertensives that have not been on the same antihypertensive regimen for at least 30 days prior to the first dose of IMP
7. Subjects having contraindications to, or interference with, MRI assessments
8. Subjects with a history of serious mental disorders that, in the opinion of the investigator, would exclude the subject from participating in this trial
9. Subjects with previous exposure to tolvaptan
18 Years
50 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Czerwiec, M.D., Ph.D.
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Otsuka Investigational Site
Huntsville, Alabama, United States
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
San Diego, California, United States
Otsuka Investigational Site 2
Aurora, Colorado, United States
Otsuka Investigational Site
Aurora, Colorado, United States
Otsuka Investigational Site
Denver, Colorado, United States
Otsuka Investigational Site
New Haven, Connecticut, United States
Otsuka Investigational Site
Jacksonville, Florida, United States
Otsuka Investigational Site
Melbourne, Florida, United States
Otsuka Investigational Site
Atlanta, Georgia, United States
Otsuka Investigational Site
Augusta, Georgia, United States
Otsuka Investigational Site
Peoria, Illinois, United States
Otsuka Investigational Site
Mishawaka, Indiana, United States
Otsuka Investigational Site
Kansas City, Kansas, United States
Otsuka Investigational Site
Paducah, Kentucky, United States
Otsuka Investigational Site
Shreveport, Louisiana, United States
Otsuka Investigational Site
Baltimore, Maryland, United States
Otsuka Investigational Site
Rockville, Maryland, United States
Otsuka Investigational Site
Boston, Massachusetts, United States
Otsuka Investigational Site
Detroit, Michigan, United States
Otsuka Investigational Site
Rochester, Minnesota, United States
Otsuka Investigational Site
Voorhees Township, New Jersey, United States
Otsuka Investigational Site
Buffalo, New York, United States
Otsuka Investigational Site
Chapel Hill, North Carolina, United States
Otsuka Investigational Site
Cleveland, Ohio, United States
Otsuka Investigational Site
Bethlehem, Pennsylvania, United States
Otsuka Investigational Site
Philadelphia, Pennsylvania, United States
Otsuka Investigational Site
Anderson, South Carolina, United States
Otsuka Investigational Site
Nashville, Tennessee, United States
Otsuka Investigational Site
Arlington, Texas, United States
Otsuka Investigational Site
Mission, Texas, United States
Otsuka Investigational Site
Charlottesville, Virginia, United States
Countries
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References
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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.
Other Identifiers
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156-09-290
Identifier Type: -
Identifier Source: org_study_id
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