Immune Tolerancei-KITCaTNCT06243289
Improving KIdney Transplantation with Cellular Therapy Study
An observational study of Immune Tolerance and Kidney Transplant Rejection, run by Western Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Tolerance, Kidney Transplant Rejection
- What is being tested?
- Tolerance induction
- How many people
- 3 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Sep 2023to 26 Feb 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study groups * Healthy control (eGFR > 90 ml/min/1.73m2 and no known medical issues) * Kidney disease with any of the following * CKD stage 5 (eGFR < 15 ml/min/1.73m2 from any cause) * Dialysis patients (haemodialysis and peritoneal dialysis) * Transplant patients (>12-months post-transplant and without prior rejection)
Who may be able to join
- able to consent, able to provide blood sample
Who cannot join
- unable to consent, life-expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving KIdney ¬Transplantation with Cellular Therapy Study
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.
Read more
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).
Read the detailed description
This observational, cohort study will be conducted at Westmead Hospital
- 3 visits over 24-months per participant.
- each consenting participant will donate 20 - 50ml of peripheral blood per visit.
- recruit n = 20 per study group (control, CKD, dialysis, and transplant).
Aims include:
- Compare generation of therapeutic grade tolerogenic dendritic cells (TolDC) from peripheral blood mononuclear cells derived from controls (healthy) and patients with kidney disease (CKD, dialysis, or transplantation).
- Perform testing of TolDC phenotype, tolerogenic capacity and yield.
- Generate hypothesis for different mechanisms of TolDC function not yet described for further characterisation to support future research
Research plan:
- Peripheral blood mononuclear cells (PBMC) will be isolated from blood by Ficoll gradient and ultrapure magnetic bead sorting.
- PBMC will be tested for purity (other unwanted immune cells) and microbiological contaminants before added to specialized DC media to generate TolDC.
- TolDC will have in depth functional characterization including flow cytometry, cytokine expression, genomic sequencing, and in-vitro testing protocols.
- TolDCs will be co-cultured with human renal cells to test protective capabilities across different AKI stimuli/insults.
This allows selection of ideal PBMC donors to generate functionally desirable TolDC for subsequent use in i-KITCaT studies.
- Conditions
- Immune Tolerance, Kidney Transplant Rejection
- Being tested
- Tolerance induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolerance inductionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Volunteers with no kidney disease, autoimmune disease or major cardiovascular comorbidities Receives: Other: Tolerance induction | |
| Participants with kidney disease | Includes patient with chronic kidney disease, dialysis or functioning transplant Receives: Other: Tolerance induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerogenic dendritic cells
Test flow cytometry, cytokine assays and mixed lymphocyte reaction to show tolerogenic potential of ex-vivo tolerogenic dendritic cells derived from peripheral blood monocytes of donors with and without kidney disease
Measured: 7 days post ex-vivo culture
Secondary outcomes (1)
Transcriptomic differences in tolerogenic dendritic cells derived from healthy and kidney disease donors
transcriptomics (RNA-seq) analysis of differential expression and pathway analysis of tolerogenic dendritic cells derived from both groups
Measured: 12-months from culture/ex-vivo generation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start19 Sep 2023
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ToleranceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Li, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243289
- Sponsor's protocol ID
- ikitcat
- Acronym
- i-KITCaT
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving KIdney ¬Transplantation with Cellular Therapy Study
- ClinicalTrials.gov ID
- NCT06243289
- Acronym / sponsor ID
- i-KITCaT / ikitcat
- Conditions
- Immune Tolerance, Kidney Transplant Rejection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 6 Feb 2024 (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.
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).
Detailed description
This observational, cohort study will be conducted at Westmead Hospital
- 3 visits over 24-months per participant.
- each consenting participant will donate 20 - 50ml of peripheral blood per visit.
- recruit n = 20 per study group (control, CKD, dialysis, and transplant).
Aims include:
- Compare generation of therapeutic grade tolerogenic dendritic cells (TolDC) from peripheral blood mononuclear cells derived from controls (healthy) and patients with kidney disease (CKD, dialysis, or transplantation).
- Perform testing of TolDC phenotype, tolerogenic capacity and yield.
- Generate hypothesis for different mechanisms of TolDC function not yet described for further characterisation to support future research
Research plan:
- Peripheral blood mononuclear cells (PBMC) will be isolated from blood by Ficoll gradient and ultrapure magnetic bead sorting.
- PBMC will be tested for purity (other unwanted immune cells) and microbiological contaminants before added to specialized DC media to generate TolDC.
- TolDC will have in depth functional characterization including flow cytometry, cytokine expression, genomic sequencing, and in-vitro testing protocols.
- TolDCs will be co-cultured with human renal cells to test protective capabilities across different AKI stimuli/insults.
This allows selection of ideal PBMC donors to generate functionally desirable TolDC for subsequent use in i-KITCaT studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Other: Tolerance inductionVolunteers with no kidney disease, autoimmune disease or major cardiovascular comorbidities |
| Participants with kidney disease | – | Other: Tolerance inductionIncludes patient with chronic kidney disease, dialysis or functioning transplant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study groups * Healthy control (eGFR > 90 ml/min/1.73m2 and no known medical issues) * Kidney disease with any of the following * CKD stage 5 (eGFR < 15 ml/min/1.73m2 from any cause) * Dialysis patients (haemodialysis and peritoneal dialysis) * Transplant patients (>12-months post-transplant and without prior rejection)
Key inclusion criteria (1 listed)
- able to consent, able to provide blood sample
Key exclusion criteria (1 listed)
- unable to consent, life-expectancy less than 6 months
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 |
|---|---|---|
| Tolerance inductionExposure 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) | Other | Healthy participants, Participants with kidney disease |
Primary outcome
Tolerogenic dendritic cells
Time frame: 7 days post ex-vivo culture
Test flow cytometry, cytokine assays and mixed lymphocyte reaction to show tolerogenic potential of ex-vivo tolerogenic dendritic cells derived from peripheral blood monocytes of donors with and without kidney disease
1 secondary outcome
Transcriptomic differences in tolerogenic dendritic cells derived from healthy and kidney disease donors
Time frame: 12-months from culture/ex-vivo generation
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Tolerance and Kidney Transplant Rejection, run by Western Sydney Local Health District at 1 site in Australia.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Mar 2025. 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 Australia. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Tolerogenic dendritic cells (time frame: 7 days post ex-vivo culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.