Decision-making support for choosing treatment in kidney disease
Official title: Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
Run by Seoul National University Hospital · NCT06618638 · Data updated 2026-11-12
This study is testing a new mobile app that helps patients with a specific type of kidney disease make better treatment choices about a medication called tolvaptan.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 9 sites (Anyang-si, Gyeonggi-do and 8 other locations) |
| Status | Recruiting |
| Started | October 21, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | November 7, 2024 |
| Trial ID | NCT06618638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of ADPKD classified as 1C, 1D, or 1E and chronic kidney disease (CKD) stage 2 or 3.
✕Probably not a fit
Patients who have previously been exposed to tolvaptan or are contraindicated to its use will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop and validate a shared decision-making (SDM) model for patients with autosomal dominant polycystic kidney disease (ADPKD) who are considering treatment with tolvaptan. The SDM model includes a patient decision aid, educational materials, and self-monitoring tools delivered through a mobile application. By evaluating the model's effectiveness and feasibility in a multi-center hybrid randomized controlled trial, the study seeks to improve treatment outcomes, patient satisfaction, adherence, and quality of life for participants. The approach emphasizes patient-centered decision-making based on individual values and preferences.
Why it matters
Potential benefit: If successful, this study could empower patients with ADPKD to make informed treatment decisions that align with their personal values and improve their overall health outcomes.
How similar studies have gone: Other studies have shown success with shared decision-making approaches in chronic disease management, indicating potential for this model to be effective as well.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants between the age of 18 to 80 * Participants with a diagnosis with CKD stage 2 or 3 * Participants with a diagnosis with ADPKD classified as 1C, 1D, or 1E according to Mayo classification * Participants with the ability to communicate and use digital devices * Participants with no severe visual impairment and cognitive dysfunction Exclusion Criteria: * Participants who were previously exposured to tolvaptan * Participants who are contraindicated to tolvaptan * Participants who were judged ineligible by the investigator
Where it's running
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Seoul National University Hospital
Seoul, Republic of Korea, South Korea Recruiting -
Hallym University Kangnam Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea Not yet recruiting -
InjeUniversityBusanPaikHospital
Busan, South Korea Not yet recruiting -
Keimyung University Dongsan Medical Center
Daegu, South Korea Not yet recruiting -
Chonnam National University Hospital
Gwangju, South Korea Not yet recruiting -
Kangbuk Samsung Hospital
Seoul, South Korea Not yet recruiting
Show 3 more locations
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Asan Medical Center
Seoul, South Korea Not yet recruiting -
Seoul National University Boramae Hospital
Seoul, South Korea Not yet recruiting -
Korea University Guro Hospital
Seoul, South Korea Not yet recruiting
Study contacts
- Principal investigator: Yong Chul Kim — Seoul National University Hospital
- Study coordinator: Jisun Chun
- Email: adpkdsdm@gmail.com
- Phone: +82-2-2072-4072
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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GV-100 first-in-human dose study in healthy adults
This early-stage study tests how GV-100 behaves and is tolerated in healthy adults to see how it might be used in people with ADPKD in the future.
-
Bempedoic Acid Therapy for ADPKD
This study tests whether bempedoic acid can help people with autosomal dominant polycystic kidney disease by slowing the progression of their kidney disease.
-
JMKX003142 for rapidly progressive ADPKD
This Phase 2 trial will test whether the oral medicine JMKX003142 is safe, well tolerated, and can slow disease progression in adults aged 18–55 with rapidly progressive ADPKD.
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Registry for patients with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
This study is collecting information from patients with Autosomal Dominant Polycystic Kidney Disease who are being treated with Tolvaptan to see how well the treatment works in real life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.