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ClinicalTrials.gov ID

NCT06852625

Lead Sponsor

Fundacion Clinic per a la Recerca BiomédicaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

30Estimated

Last Update Posted

Feb 28, 2025Actual

Start Date

May 2025Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 2028Estimated

Official Title

Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients

Brief 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.

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.

• Kidney Transplant Rejection

• Autologous Tolerogenic Dendritic Cells

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
3. Adequate venous access and absence of contraindications for leukoapheresis.
4. Women of childbearing age must take contraceptive measures.
5. Must have given written informed consent

Exclusion Criteria:

1. Subjects with active TB.
2. Patients on the waiting list multiple organ transplants.
3. 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.
4. HIV-positive subjects.
5. Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
6. Subjects with active CMV or EBV infection as defined by positive PCR.
7. Subjects with a known history of previous myocardial infarction within one year of screening.
8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
9. Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
10. Pregnant and lactating women.

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Fundacion Clinic per a la Recerca BiomédicaOTHER

mcrespo@psmar.cat+34932483689

cfacundo@fundacio-puigvert.es+34934169700

francescjosep.moreso@vallhebron.cat+34932746000

fdiekman@clinic.cat+34932275444