Efficacy of Tolvaptan on ADPKD Patients (NCT02729662) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of Tolvaptan on ADPKD Patients
Japan118 participantsStarted 2016-10-01
Plain-language summary
Investigation of the therapeutic effects of tolvaptan in patients with autosomal dominant polycystic kidney disease This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 5 years (data cut-off, Aug 31, 2020).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who have started or will start receiving tolvaptan at Kyorin University Hospital.
. Patients whose use of Samsca complies with the criteria specified by the Ministry of Health, Labour and Welfare.
. Patients who have given signed consent to the examination protocol, which includes hospitalization at the initiation of tolvaptan treatment (i.e. examination/educational hospitalization for the first 3 days. Monthly blood tests at the time of ambulatory visits, 24-hour urine collection every 6 months, annual TKV measurement by MRI and inulin clearance measurement)
. Patients for whom the baseline TKV and eGFR percent change is available.
. Patients from whom freely given, written informed consent to participate in the study has been obtained.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring the percent change in total kidney volume — can you explain what that means for my kidney health, and whether tracking kidney size is the right goal for where I am in my ADPKD progression?
2Tolvaptan is already approved for ADPKD in some cases — how does participating in this study differ from simply being prescribed tolvaptan as a standard treatment, and which path might make more sense for me?
3The recruitment status for this trial is listed as unknown — do you know whether this study is still actively enrolling patients, and how would we even find out if it's a real option for me right now?
4This trial doesn't list a specific phase, which is unusual — what does that tell us about how much is already known about tolvaptan's safety and effectiveness, and are there any risks I should be especially aware of?
5Given that tolvaptan has known side effects like liver toxicity and increased thirst and urination, how would my current health and lifestyle hold up to those demands if I were to discuss joining a study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percent change in TKV volumetrically
Timeframe: once a year, up to study completion, an expected average of up to 5 years
. Patients who do not consent to participation in the study, or those who later withdraw their consent.
. Patients who have been taking tolvaptan since the TEMPO study.
. Patients who are not eligible at our hospital to take tolvaptan for the stated indication based on the criteria for careful administration of Samsca as specified by the Ministry of Health, Labour and Welfare.