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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01214421




Registration number
NCT01214421
Ethics application status
Date submitted
26/09/2010
Date registered
5/10/2010

Titles & IDs
Public title
Tolvaptan Extension Study in Participants With ADPKD
Scientific title
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)
Secondary ID [1] 0 0
2010-018401-10
Secondary ID [2] 0 0
156-08-271
Universal Trial Number (UTN)
Trial acronym
TEMPO 4/4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease (ADPKD) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
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

Experimental: 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.


Treatment: Drugs: Tolvaptan
Tablets of 15 or 30 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)
Timepoint [1] 0 0
Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271)
Secondary outcome [1] 0 0
Change From the Baseline in Estimated Glomerular Filtration Rate (eGFR) as Assessed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) for Study 156-04-251 Participants Enrolled in This Study (156-08-271)
Timepoint [1] 0 0
Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271)
Secondary outcome [2] 0 0
Annualized Slope of Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in Study 156-08-271
Timepoint [2] 0 0
Study Baseline (Prior to Day 1 in Study 156-08-271) to Month 24 in this study (Study 156-08-271)
Secondary outcome [3] 0 0
Annualized Slope of eGFR (CKD-EPI) for Study 156-04-251 Participants Enrolled in Study 156-08-271
Timepoint [3] 0 0
Study Baseline (Prior to Day 1 in Study 156-08-271) to Month 24 (Study 156-08-271)
Secondary outcome [4] 0 0
Annualized TKV Slope for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271
Timepoint [4] 0 0
Tolvaptan, Delayed Treated: Baseline to Month 24 in Study 156-08-271; Placebo: Baseline to Month 36 in Study 156-04-251
Secondary outcome [5] 0 0
Annualized Slope of Renal Function (eGFRCKD-EPI) for Study 156-04-251 Placebo Participants Enrolled in Study 156-08-271
Timepoint [5] 0 0
Tolvaptan, Delayed Treated: Baseline to Month 24 in Study 156-08-271; Placebo: Baseline to Month 36 in Study 156-04-251

Eligibility
Key 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)].
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/02/2016
Sample size
Target
Accrual to date
Final
1083
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Otsuka Investigational Site - St. Leonards
Recruitment hospital [2] 0 0
Otsuka Investigational Site - Westmead
Recruitment hospital [3] 0 0
Otsuka Investigational Site - Woolloongabba
Recruitment hospital [4] 0 0
Otsuka Investigational Site - Adelaide
Recruitment hospital [5] 0 0
Otsuka Investigational Site - Parkville
Recruitment hospital [6] 0 0
Otsuka Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Louisiana
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Massachusetts
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Modena
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Pavia
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Amsterdam
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Groningen
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Ciechanów
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Krakow
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Lodz
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Lublin
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Wroclaw
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Romania
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Bucuresti
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Romania
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Iasi
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Russian Federation
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Kemerovo
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Belfast
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Birmingham
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Brighton
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Coventry
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Edinburgh
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Inverness
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London
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United Kingdom
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Otsuka Pharmaceutical Development & Commercialization, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Available to whom?
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinical-trials.otsuka.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01214421