Kidney Transplant FailurePRIMA-AINCT06056518
Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
A study testing AI-based risk prediction for kidney graft loss in people with Kidney Transplant Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure
- What is being tested?
- AI-based risk prediction for kidney graft loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jan 2024to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
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 months follow-up. Implementation barriers and enablers will also be assessed. The protocol was amended so that the initially planned 24 months observation timeframe was removed from the study and it ended after 12 months due to high attrition and funding restrictions.
- Conditions
- Kidney Transplant Failure
- Being tested
- AI-based risk prediction for kidney graft loss
- Keywords
- Kidney Transplantation, Graft Loss, Kidney Transplant Failure, Riks Prediction System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based risk prediction for kidney graft lossOther
Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center. |
| AI-supported Care | Experimental | Patients in the "AI-supported Care" arm will undergo regular follow-up at the kidney transplant center. Treating physicians will be provided an AI-based risk prediction tool that predict 1-year risk of graft loss for patients in this group based on routine parameters. Receives: Other: AI-based risk prediction for kidney graft loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
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)
Measured: 12 months
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)
Measured: 12 months
Kidney replacement therapy 12 months
Frequency of kidney replacement therapy after graft loss 12 months
Measured: 12 months
Emergency dialysis 12 months
Frequency of emergency dialysis after graft loss 12 months
Measured: 12 months
Dialysis initiation via AV-shunt 12 months
Frequency of dialysis initiation via AV-shunt after graft loss 12 months
Measured: 12 months
Dialysis initiation via permanent catheter 12 months
Frequency of dialysis initiation via permanent catheter after graft loss 12 months
Measured: 12 months
Retransplantation 12 months
Frequency of retransplantation after graft loss 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Jan 2024
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klemens Budde, Charite University, Berlin, Germany
- Investigators
- Klemens Budde, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056518
- Sponsor's protocol ID
- CHA-PRIMA-AI
- Acronym
- PRIMA-AI
- Status last verified
- May 2026
- First submitted
- 21 Sep 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osmanodja B, Sassi Z, Eickmann S, Hansen CM, Roller R, Burchardt A, Samhammer D, Dabrock P, Moller S, Budde K, Herrmann A. Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54857. doi: 10.2196/54857.
PubMed 38557315
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
- ClinicalTrials.gov ID
- NCT06056518
- Acronym / sponsor ID
- PRIMA-AI / CHA-PRIMA-AI
- Conditions
- Kidney Transplant Failure
- Keywords
- Kidney Transplantation, Graft Loss, Kidney Transplant Failure, Riks Prediction System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 months follow-up. Implementation barriers and enablers will also be assessed. The protocol was amended so that the initially planned 24 months observation timeframe was removed from the study and it ended after 12 months due to high attrition and funding restrictions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center. |
| AI-supported Care | Experimental | Other: AI-based risk prediction for kidney graft lossPatients in the "AI-supported Care" arm will undergo regular follow-up at the kidney transplant center. Treating physicians will be provided an AI-based risk prediction tool that predict 1-year risk of graft loss for patients in this group based on routine parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based risk prediction for kidney graft lossImplementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss. | Other | AI-supported Care |
Primary outcome
Conversation about kidney replacement therapy after graft loss
Time frame: 12 months
Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed
7 secondary outcomes
CollaboRATE mean score after 12 months
Time frame: 12 months
Control Preferences Scale mean after 12 months
Time frame: 12 months
Kidney replacement therapy 12 months
Time frame: 12 months
Emergency dialysis 12 months
Time frame: 12 months
Dialysis initiation via AV-shunt 12 months
Time frame: 12 months
Dialysis initiation via permanent catheter 12 months
Time frame: 12 months
Retransplantation 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 38557315Osmanodja B, Sassi Z, Eickmann S, Hansen CM, Roller R, Burchardt A, Samhammer D, Dabrock P, Moller S, Budde K, Herrmann A. Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54857. doi: 10.2196/54857.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klemens Budde, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based risk prediction for kidney graft loss in people with Kidney Transplant Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversation about kidney replacement therapy after graft loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.