Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06243289




Registration number
NCT06243289
Ethics application status
Date submitted
28/01/2024
Date registered
6/02/2024
Date last updated
28/02/2024

Titles & IDs
Public title
Improving KIdney Transplantation With Cellular Therapy Study
Scientific title
Improving KIdney ¬Transplantation With Cellular Therapy Study
Secondary ID [1] 0 0
ikitcat
Universal Trial Number (UTN)
Trial acronym
i-KITCaT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Tolerance 0 0
Kidney Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Tolerance induction

Healthy participants - Volunteers with no kidney disease, autoimmune disease or major cardiovascular comorbidities

Participants with kidney disease - Includes patient with chronic kidney disease, dialysis or functioning transplant


Other interventions: Tolerance induction
Exposure of peripheral blood mononuclear cells extracted from donated patient blood to a combination of vitamin D3 and interleukin 10 to test whether tolerogenic dendritic cells can be generated and have the same functional capacity between donors with and without kidney disease (exposure of PBMC to the uremic environment)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tolerogenic dendritic cells
Timepoint [1] 0 0
7 days post ex-vivo culture
Secondary outcome [1] 0 0
Transcriptomic differences in tolerogenic dendritic cells derived from healthy and kidney disease donors
Timepoint [1] 0 0
12-months from culture/ex-vivo generation

Eligibility
Key inclusion criteria
- able to consent, able to provide blood sample
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- unable to consent, life-expectancy less than 6 months

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The i-KITCaT study aims to harness cellular therapies to favourably alter the immunological
response to in AKI in transplantation. Kidney transplantation offers the best survival and
quality of life outcomes for patients with end-stage kidney disease but requires life-long
immunosuppression. Efforts to increase the donor organ pool means accepting kidneys which
have been subjected to medical and surgical factors culminating in acute kidney injury (AKI).

There is no treatment to modify the maladaptive injury process following an AKI insult, and
this subjects the new kidney to increased risk of needing dialysis in the first 7 days of
transplantation, rejection, and shortened transplant survival.

Tolerogenic dendritic cells (TolDC) are currently used in phase I/II clinical trials and are
safe for patients receiving a kidney transplant from the same donor as these cells. These
trials focus on transplant tolerance, but we will re-purpose TolDCs to favorably alter the
disease course following AKI and limit injury following transplantation.

Furthermore, if the patient's own cells (rather than from a third-party donor) can be used,
this avoids supply limitations and potential sensitization risk. We will compare the
functional characteristics of TolDC generated from control (healthy) and kidney disease
(chronic kidney disease (CKD), dialysis and transplantation).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06243289
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06243289