Trial from ClinicalTrials.gov

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Trial ID
NCT02251275
Ethics application status
Date submitted
25/09/2014
Date registered
25/09/2014
Date last updated
20/06/2017

Titles & IDs
Public title
Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Scientific title
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease
Secondary ID [1] 0 0
156-13-211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - Tolvaptan (OPC-41061)

Experimental: Tolvaptan (OPC-41061) -


Treatment: drugs: Tolvaptan (OPC-41061)
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

Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety variables - Clinically significant changes from baseline in abnormal clinical laboratory tests, vital signs and AEs will be summarized.The incidence of the following events will be summarized:
Treatment-emergent AEs (TEAEs) by severity
TEAEs potentially causally related to tolvaptan
TEAEs with an outcome of death
Serious TEAEs
Discontinuations due to TEAEs
Clinically significant serum transaminase elevations will be summarized by frequency (2x, 3x, 5x and 10x ULN), time to onset, time to peak levels, time to offset (< 3x, 2x, or 1x ULN)
Frequency of progression to Hy's laboratory criteria (ALT or AST > 3x ULN and bilirubin, total (BT), > 2x ULN without alkaline phosphatase > 2x ULN)
Serum sodium excursions above 145, 150, or 155 mmol/L or below 135, 130, or 125 mmol/L
Timepoint [1] 0 0
From Baseline

Eligibility
Key inclusion criteria
1. Male and female subjects = 18 years with confirmed diagnosis of ADPKD (during
participation in prior tolvaptan trials) who have

- Completed and transferred from the double-blind Trial 156-13-210 (12-month period
including post treatment follow-up, regardless of whether this was on-treatment
or off-treatment), or

- Completed Trial 156-08-271 or a prior tolvaptan trial, or

- Interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than
Trial 156-13-210. Subjects may be enrolled with the medical monitor approval, and
additional close monitoring may be required at the beginning of the study

2. Estimated glomerular filtration rate (eGFR) = 20 mL/min/1.73m2 within 45 days of the
baseline visit. Subjects who have an eGFR between 15 and 19 mL/min/1.73m2 may be
enrolled with medical monitor approval

3. Diagnosis of ADPKD by modified Pei-Ravine criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Need for chronic diuretic use

- Hepatic impairment based on liver function assessments other than that expected for
ADPKD with cystic liver disease

- Women of childbearing potential (WOCBP) 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 IMP

- Women who are breast-feeding and/or who have a positive pregnancy test result prior to
receiving IMP.

- Subjects with contraindications to required trial assessments (contraindications to
optional assessments, eg, MRI are not a limitation).

- Subjects who in the opinion of the Investigator or the Medical Monitor, have a medical
history or medical finding inconsistent with safety or trial compliance

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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- Camperdown
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- New Lambton Heights
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- St Leonards
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- Westmead
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- Woolloongabba
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- Adelaide
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- Launceston
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- Melbourne
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- Reservoir
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- Richmond
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- Perth
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2050 - Camperdown
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2305 - New Lambton Heights
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2065 - St Leonards
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2145 - Westmead
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4102 - Woolloongabba
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5000 - Adelaide
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7250 - Launceston
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3050 - Melbourne
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3073 - Reservoir
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3121 - Richmond
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate and describe the long term safety of tolvaptan in
patients with autosomal dominant polycystic kidney disease (ADPKD
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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