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A clinical trial applying Regulatory T cells in kidney transplant recipients to investigate the safety and tolerability as an adjunctive therapy to the standard immunosuppressive therapy
EU CTIS ID: 2024-514398-23-00
What this study is testing
Determine whether administering polyclonal ex-vivo expanded autologous Tregs to deceased donor kidney transplant recipients is safe. Investigate if adoptive Treg therapy modulates the immunological response such that the kidney transplant is tolerated and safe. Yield preliminary data that Treg therapy could potentially enable maintenance immunosuppressive therapy tapering or elimination, thereby improving recipients’ long-term prognosis.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Chronic renal insufficiency with a GFR < 15 ml/min x 1.73 m², accepted by the organ transplantation conference, registered by ET (Eurotransplant; www.eurotransplant.org)
- Age: 18 – 70 years of age
- Willing and able to participate in the trial
- Signed and dated written informed consent.* (*For patients unable to read and/or write, an oral informed consent observed by an independent witness is acceptable, if the patient has fully understood the oral information given by the Investigator. The witness should sign the consent form on behalf of the patient.)
- Haematology: Hb ≥7.0 g/dl; platelets ≥80x10^9/l; total leukocyte count: ≥3.0x10^9/l
- Karnofsky score: 40 – 90
You likely can't join if
- Patient has previously received any tissue or organ transplant other than the planned kidney graft
- Female patients who are breast-feeding
- All female patients of childbearing age* unless the patient is willing to maintain a highly effective method of birth control** for the duration of the study
- Known contraindication to protocol-specified treatments / medications
- AL amyloidosis with significant extrarenal involvement
- Decompensated cirrhosis
See the full eligibility criteria
- Chronic renal insufficiency with a GFR < 15 ml/min x 1.73 m², accepted by the organ transplantation conference, registered by ET (Eurotransplant; www.eurotransplant.org)
- Age: 18 – 70 years of age
- Willing and able to participate in the trial
- Signed and dated written informed consent.* (*For patients unable to read and/or write, an oral informed consent observed by an independent witness is acceptable, if the patient has fully understood the oral information given by the Investigator. The witness should sign the consent form on behalf of the patient.)
- Haematology: Hb ≥7.0 g/dl; platelets ≥80x10^9/l; total leukocyte count: ≥3.0x10^9/l
- Karnofsky score: 40 – 90
- Donor eligibility criteria: Individuals 18 years of age or more are eligible as donors. However, potential donors >50 years will be not eligible if they have more than 2 of the following risk factors; hypertension or serum creatinine >1.5 mg/dl at the time of explantation or an anticipated cold ischemia time of >24 h.
- Patient has previously received any tissue or organ transplant other than the planned kidney graft
- Female patients who are breast-feeding
- All female patients of childbearing age* unless the patient is willing to maintain a highly effective method of birth control** for the duration of the study
- Known contraindication to protocol-specified treatments / medications
- AL amyloidosis with significant extrarenal involvement
- Decompensated cirrhosis
- Severe irreversible obstructive or restrictive lung disease
- Severe uncorrectable and symptomatic cardiac disease that is deemed by cardiologists to preclude transplantation
- Progressive central neurodegenerative disease
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any form of drug or alcohol abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- HIV-positive or suffering chronic viral hepatitis
- Patients unable to give their informed consent (e.g. patients under legal guardianship)
- Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Known allergy/hypersensitivity to any component of the study product
- Positive SARS-CoV-2 RT-PCR test
- Persons who demonstrate dependency from the sponsor, investigator or trial site
- Panel-reactive antibodies (PRA) grade > 20% within last 6 months before enrolment
- Previous treatment with any desensitization procedure with or without intravenous immunoglobulin
- Concomitant malignancy or history of malignancy within 5 years prior to study inclusion in the trial (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin or curatively treated renal cell carcinoma with complete nephrectomy)
- Evidence of significant local or systemic infection
- EBV-negative recipient receiving a kidney from an EBV-positive deceased-donor
- Significant liver disease, defined as persistently elevated AST and/or ALT levels > 2 x ULN (Upper Limit of Normal range)
- Malignant or pre-malignant haematological conditions. Multiple myeloma, light or heavy chain deposition disease
- Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
- Any condition which, according to the PI, would place the subject at undue risk
- Ongoing treatment with systemic immunosuppressive drugs at study entry
- Participation in another clinical trial during the study or within 5 times as the half-life time of the drug used in the previous trial prior to planned study entry
- Female patients of childbearing age with a positive pregnancy test at enrolment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.