Kidney Transplant Rejection Clinical Trial
— i-KITCaTOfficial title:
Improving KIdney ¬Transplantation With Cellular Therapy Study
NCT number | NCT06243289 |
Other study ID # | ikitcat |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 19, 2023 |
Est. completion date | January 1, 2027 |
Verified date | February 2024 |
Source | Western Sydney Local Health District |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - able to consent, able to provide blood sample Exclusion Criteria: - unable to consent, life-expectancy less than 6 months |
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Westmead | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Western Sydney Local Health District |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 7 days post ex-vivo culture | |
Secondary | 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 | 12-months from culture/ex-vivo generation |
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