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Recruiting Not applicable

Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

NCT06618638 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2024-10-21
Last updated
2024-11-07

Condition(s) studied

ADPKD (autosomal Dominant Polycystic Kidney Disease)

Investigational drug(s) / intervention(s)

Shared decision making modelUsual Care

Shared decision making model: Shared decision making model for choosing pharmacotherapy in ADPKD patients. This newly developed shared decision making model follows the SHARE approach and includes patient education, identifying values and preferences, reaching a decision and evaluating.

Usual Care: Usual care for ADPKD patients

Study summary

The purpose of this study is to generate clinical evidence and assess the feasibility of a shared decision-making (SDM) model for the selection of Tolvaptan in patients with ADPKD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percent change in htTKV from baseline to 12 months — From enrollment to the end of treatment at 1 months
    Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months.

Trial sites (9)

FacilityCityRegionStatus
Hallym University Kangnam Sacred Heart Hospital Anyang-si Gyeonggi-do Not Yet Recruiting
Seoul National University Hospital Seoul Republic of Korea 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
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06618638 on ClinicalTrials.gov ↗ ← All trials in South Korea