Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date February 2024
Source Western Sydney Local Health District
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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: 1. 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). 2. Perform testing of TolDC phenotype, tolerogenic capacity and yield. 3. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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)

Locations

Country Name City State
Australia Westmead Hospital Westmead New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04491552 - TruGraf® Long-term Clinical Outcomes Study
Withdrawn NCT04560582 - Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Completed NCT05747274 - SRDK0921_ Analytical Performance Study
Not yet recruiting NCT05482100 - CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT04367610 - Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Enrolling by invitation NCT06126380 - Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients Phase 2
Terminated NCT05747053 - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Active, not recruiting NCT03714113 - Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients N/A
Recruiting NCT04091984 - The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Recruiting NCT05335538 - TruGraf and TRAC In Pediatrics Study
Completed NCT03663335 - Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients Phase 2
Completed NCT03652402 - Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
Recruiting NCT04773392 - Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR Phase 4
Completed NCT03873623 - The TOGETHER Project - Kidney
Terminated NCT02974686 - Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation Phase 4
Terminated NCT04156204 - Immunosuppressant Medication Dosed Daily After Kidney Transplant Early Phase 1
Completed NCT04601155 - Transition of Renal Patients Using AlloSure Into Community Kidney Care
Completed NCT03874299 - The TOGETHER Project - Kidney RNA-seq Validation
Completed NCT03965559 - The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant