Kidney Transplant RejectionPhase 1ATDC-PICINCT06852625
Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients
A Phase 1 study testing Autologous Tolerogenic Dendritic Cells in people with Kidney Transplant Rejection, run by Fundacion Clinic per a la Recerca Biomédica at 7 sites in Spain.
Trial summary
The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Autologous Tolerogenic Dendritic Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesSpain
- Study dates
- May 2025to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
- To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
- Adequate venous access and absence of contraindications for leukoapheresis.
- Women of childbearing age must take contraceptive measures.
- Must have given written informed consent
Who cannot join
- Subjects with active TB.
- Patients on the waiting list multiple organ transplants.
- A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3x upper limit.
- HIV-positive subjects.
- Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
- Subjects with active CMV or EBV infection as defined by positive PCR.
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- Subjects with a known history of previous myocardial infarction within one year of screening.
- Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
- Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
- Pregnant and lactating women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Anna Vila Santandreu, +34934978898, annavilas.germanstrias@gencat.cat
Hospital del Mar
Barcelona, Barcelona, 08003
Marta Crespo Barrio, +34932483689, mcrespo@psmar.cat
Fundació Puigvert
Barcelona, Barcelona, 08025
Carme Facundo, +34934169700, cfacundo@fundacio-puigvert.es
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Francesc Josep Moreso Mateos, +34932746000, francescjosep.moreso@vallhebron.cat
Hospital Clinic Barcelona
Barcelona, Barcelona, 08036
Fritz Diekmann, +34932275444, fdiekman@clinic.cat
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Edoardo Melilli, +34932607385, emelilli@bellvitgehospital.cat
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
Alex Gutiérrez Dalmau, +34976765500, alexgutierrezd@gmail.com
About this study
The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.
Read the detailed description
The study population is sensitized kidney transplant candidates (cPRA ≥ 90%) between 18 and 65 years.
An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.
Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).
- 30 highly sensitized patients will be pre-included in the study.
- The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will be included in the study.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Autologous Tolerogenic Dendritic Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tolerogenic Dendritic CellsBiological
- Autologous Tolerogenic Dendritic Cells (D+1 to D+3 post-transplantation), ATDC, 1 million ATDC/Kg over a period of 30 minutes (up to 1 hour) will administer between Day 1 and Day 3 after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.
Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).
* 30 highly sensitized patients will be pre-included in the study.
* The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will receive study treatment. Receives: Biological: Autologous Tolerogenic Dendritic Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.
Proportion of patients with toxicity/side effects during and after administration.
Measured: at day 1 and day 3
Secondary outcomes (7)
Rate of infectious disease that required hospitalization at 6 and 12 months.
Proportion of patients with severe or serious infections at 6 months and 12 months.
Measured: at 6 months and 12 months.
To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC
Incidence of BPAR at 3 and 12months after transplantation.
Measured: at 3 and 12months after transplantation.
To evaluate renal function up to 1 year after transplantation
Renal function at 3, 6 and 12 months after transplantation as assessed by estimated glomerular filtration rate (eGFR)
Measured: at 3, 6 and 12 months after transplantation
To evaluate renal function up to 1 year after transplantation
Renal function at 3, 6 and 12 months after transplantation as assessed by serum/plasma creatinine levels
Measured: at 3, 6 and 12 months after transplantation
To evaluate patient survival
Patient survival at 12 months after transplantation
Measured: at 12 months after transplantation
To evaluate graft survival
Graft survival at 12 months after transplantation
Measured: at 12 months after transplantation
To characterize the immunophenotype status.
Define the different cell subtypes in circulating cells, as well as the functionality of T and B cells using ELISpot and Fluorospot techniques
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852625
- Sponsor's protocol ID
- 2024-519978-39-00
- Acronym
- ATDC-PICI
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06852625
- Acronym / sponsor ID
- ATDC-PICI / 2024-519978-39-00
- Conditions
- Kidney Transplant Rejection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Feb 2025 (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 ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.
Detailed description
The study population is sensitized kidney transplant candidates (cPRA ≥ 90%) between 18 and 65 years.
An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.
Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).
- 30 highly sensitized patients will be pre-included in the study.
- The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will be included in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Autologous Tolerogenic Dendritic CellsAn algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry. Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15). * 30 highly sensitized patients will be pre-included in the study. * The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will receive study treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
- To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
- Adequate venous access and absence of contraindications for leukoapheresis.
- Women of childbearing age must take contraceptive measures.
- Must have given written informed consent
Key exclusion criteria (10 listed)
- Subjects with active TB.
- Patients on the waiting list multiple organ transplants.
- A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3x upper limit.
- HIV-positive subjects.
- Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
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 |
|---|---|---|
| Autologous Tolerogenic Dendritic Cells• Autologous Tolerogenic Dendritic Cells (D+1 to D+3 post-transplantation), ATDC, 1 million ATDC/Kg over a period of 30 minutes (up to 1 hour) will administer between Day 1 and Day 3 after transplantation. | Biological | Treatment |
Primary outcome
Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.
Time frame: at day 1 and day 3
Proportion of patients with toxicity/side effects during and after administration.
7 secondary outcomes
Rate of infectious disease that required hospitalization at 6 and 12 months.
Time frame: at 6 months and 12 months.
To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC
Time frame: at 3 and 12months after transplantation.
To evaluate renal function up to 1 year after transplantation
Time frame: at 3, 6 and 12 months after transplantation
To evaluate renal function up to 1 year after transplantation
Time frame: at 3, 6 and 12 months after transplantation
To evaluate patient survival
Time frame: at 12 months after transplantation
To evaluate graft survival
Time frame: at 12 months after transplantation
To characterize the immunophenotype status.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Tolerogenic Dendritic Cells in people with Kidney Transplant Rejection, run by Fundacion Clinic per a la Recerca Biomédica at 7 sites in Spain.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fritz Diekmann, Dr (+34932775444, fdiekman@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor. (time frame: at day 1 and day 3). 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 Feb 2025.