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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06056518
Other study ID # CHA-PRIMA-AI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2024
Est. completion date July 2026

Study information

Verified date February 2024
Source Charite University, Berlin, Germany
Contact Klemens Budde, MD
Phone 0049 30 450 614 086
Email klemens.budde@charite.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to analyze the effects of AI-based risk prediction for graft loss on the frequency of conversations about the treatment after graft loss, as well as the associated shared decision making process in post-kidney transplant care in a German kidney transplant center (KTC), as perceived by the patient, their support person and the clinician/physician. Second, it aims to explore changes in patient and support person recall at 12 and 24 months follow-up. Implementation barriers and enablers will also be assessed.


Recruitment information / eligibility

Status Recruiting
Enrollment 122
Est. completion date July 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - written informed consent - patients with functioning kidney allograft - > 12 months after transplantation - eGFR < 30 ml/min/1.73m2 according to CKD-EPI 2021 formula - at least 18 years of age - ability to communicate in German - regular follow-up at kidney transplant center Exclusion Criteria: - multi-organ transplantation - eGFR > 30 ml/min/1.73m2 according to CKD-EPI 2021 formula - <= 12 months after transplantation - less than 18 years of age - not able to communicate in German - no regular follow-up at kidney transplant center - enrollment in another interventional study less than 1 month before participation in this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
AI-based risk prediction for kidney graft loss
Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.

Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative analysis of semistructured interviews Qualitative analysis of semistructured interviews after 24 months 24 months
Other Qualitative analysis of physician-patient conversations Qualitative analysis of physician-patient conversations after 24 months 24 months
Primary Conversation about kidney replacement therapy after graft loss Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed 12 months
Secondary CollaboRATE mean score after 12 months CollaboRATE mean score of all study visits from study inclusion until month 12 (values 0 - 9, higher values indicating better outcome) 12 months
Secondary CollaboRATE mean score after 24 months CollaboRATE mean score of all study visits from study inclusion until month 24 (values 0 - 9, higher values indicating better outcome) 24 months
Secondary Control Preferences Scale mean after 12 months Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome) 12 months
Secondary Control Preferences Scale mean after 24 months Mean Control Preferences Scale of all study visits from study inclusion until month 24 (values 1 - 5, higher values indicating better outcome) 24 months
Secondary Kidney replacement therapy 12 months Frequency of kidney replacement therapy after graft loss 12 months 12 months
Secondary Kidney replacement therapy 24 months Frequency of kidney replacement therapy after graft loss 24 months 24 months
Secondary Emergency dialysis 12 months Frequency of emergency dialysis after graft loss 12 months 12 months
Secondary Emergency dialysis 24 months Frequency of emergency dialysis after graft loss 24 months 24 months
Secondary Dialysis initiation via AV-shunt 12 months Frequency of dialysis initiation via AV-shunt after graft loss 12 months 12 months
Secondary Dialysis initiation via AV-shunt 24 months Frequency of dialysis initiation via AV-shunt after graft loss 24 months 24 months
Secondary Dialysis initiation via permanent catheter 12 months Frequency of dialysis initiation via permanent catheter after graft loss 12 months 12 months
Secondary Dialysis initiation via permanent catheter 24 months Frequency of dialysis initiation via permanent catheter after graft loss 24 months 24 months
Secondary Retransplantation 12 months Frequency of retransplantation after graft loss 12 months 12 months
Secondary Retransplantation 24 months Frequency of retransplantation after graft loss 24 months 24 months
Secondary Conversation about kidney replacement therapy after graft loss Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed 24 months
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