Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment

NCT06618638 | Recruiting

• 1 other identifier: HV23C182600
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

ADPKD (autosomal Dominant Polycystic Kidney Disease)

Keywords

Autosomal Dominant Polycystic Kidney Disease; Shared Decision Making; Hybrid Randomized Controlled Trial type 1; Tolvaptan

Outcome Measures

Primary Outcomes (1)

• Percent change in htTKV from baseline to 12 months

  Calculate percent change in height adjusted total kidney volume (htTKV) from baseline to 12 months.

  From enrollment to the end of treatment at 1 months

Study Arms (2)

SDM group

EXPERIMENTAL

SDM group receives treatment using a shared decision-making model.

Behavioral: Shared decision making model

Conventional group

OTHER

Conventional group receives treatment as usual.

Behavioral: Usual Care

Interventions

Shared decision making model BEHAVIORAL

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.

SDM group

Usual Care BEHAVIORAL

Usual care for ADPKD patients

Conventional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants who were previously exposured to tolvaptan
• Participants who are contraindicated to tolvaptan
• Participants who were judged ineligible by the investigator

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University: collaborator
• Hallym University Kangnam Sacred Heart Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator
• Korea University Guro Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator
• Asan Medical Center: collaborator
• InjeUniversityBusanPaikHospital: collaborator
• Chonnam National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (9)

Hallym University Kangnam Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, Republic of Korea, 03080, South Korea

RECRUITING

InjeUniversityBusanPaikHospital

Busan, 47392, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

NOT YET RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

NOT YET RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Seoul National University Boramae Hospital

Seoul, 07061, South Korea

NOT YET RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Yong Chul Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jisun Chun

CONTACT

+82-2-2072-4072; adpkdsdm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

KR (9)