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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00428948




Registration number
NCT00428948
Ethics application status
Date submitted
26/01/2007
Date registered
30/01/2007
Date last updated
2/07/2017

Titles & IDs
Public title
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Scientific title
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
Secondary ID [1] 0 0
2006-002768-24
Secondary ID [2] 0 0
156-04-251
Universal Trial Number (UTN)
Trial acronym
TEMPO3:4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Kidney Disease, Autosomal Dominant 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
Treatment: Drugs - Placebo

Experimental: Tolvaptan - Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.

Placebo comparator: Placebo - Participants received placebo (upon awakening and 9 hours later) orally for 36 months.


Treatment: Drugs: Tolvaptan
Tolvaptan was supplied as tablets.

Treatment: Drugs: Placebo
Placebo was supplied as tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
Timepoint [1] 0 0
Baseline to Month 36
Secondary outcome [1] 0 0
Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36
Timepoint [1] 0 0
Baseline to Month 36
Secondary outcome [2] 0 0
Change in Renal Function Per Year From Week 3 to Month 36
Timepoint [2] 0 0
Week 3 to Month 36
Secondary outcome [3] 0 0
Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36
Timepoint [3] 0 0
Baseline to Month 36
Secondary outcome [4] 0 0
Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36
Timepoint [4] 0 0
At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2
Secondary outcome [5] 0 0
Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36
Timepoint [5] 0 0
Baseline to Month 36
Secondary outcome [6] 0 0
Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36
Timepoint [6] 0 0
Baseline to Month 36

Eligibility
Key inclusion criteria
* Legal adult age and able to give Informed Consent.
* Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.
* Willingness to comply with reproductive precautions, if female.
* Estimated creatinine clearance = 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.
* Rapidly progressive kidney growth (total volume = 750 cc) by magnetic resonance imaging (MRI) at randomization.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to tolvaptan or other experimental PKD therapies.
* Currently taking medication for purpose of affecting PKD cysts.
* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
* In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives.
* Patients who are unlikely to adequately comply with study procedures.
* Patients having contraindications to MRI.
* Patients taking medications or having any illnesses likely to affect ADPKD outcomes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
1445
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Queen Elizebeth Hospital - Adelaide
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
Melbourne Renal Research Group - Melbourne
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [8] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5011 - Adelaide
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment postcode(s) [5] 0 0
3121 - Melbourne
Recruitment postcode(s) [6] 0 0
6054 - Perth
Recruitment postcode(s) [7] 0 0
2065 - Sydney
Recruitment postcode(s) [8] 0 0
2145 - Sydney
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Romania
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Inverness
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Sheffield
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Otsuka Pharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Vicente Torres, MD, PhD
Address 0 0
Mayo Medical Center
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

No information has been provided regarding IPD availability


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/NCT00428948