Kidney Transplant Failure and RejectionPhase 1ECPNCT07083830
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
A Phase 1 study testing ECP-DL treated mononuclear cell infusion in people with Kidney Transplant Failure and Rejection and Kidney Transplant; Complications, run by Northwestern University.
Trial summary
This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients. 2) Determine rates of graft rejection and compare to historical controls. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
- What is being tested?
- ECP-DL treated mononuclear cell infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2027to 25 Dec 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient age ≥30 and less than 70 years old.
- Donor age ≥18 and ≤ 70 years old.
- Recipient of a first kidney transplant from a living unrelated or living related donor that is not HLA-identical to the donor.
- Donor willing to undergo cell collection for ECP-DL cell preparation and infusion.
- Donors will be screened and tested for HIV-1 (antigen and nucleic acid), HIV-2, hepatitis B virus (HBV, nucleic acid and surface and core antigen), hepatitis C virus (HCV, antigen and nucleic acid), Treponema pallidum (syphilis), West Nile Virus (WNV), and CJD (screening only). and tested for human T-lymphotropic virus types 1 and 2 (HTLV-1, HTLV-2) and CMV, in accordance with established UNOS guidelines for solid organ donors.
- Donors and recipients who test negative for TB using QuantiFERON gold assay.
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- Must be willing and able to comply with protocol-required visit schedule and visit requirement.
- Patients who are single-organ recipients (kidney only).
- Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period. Both male and female transplant recipients must agree to the use of highly effective birth control for 12 months following ECP-DL procedure. Individuals unwilling to do so will be excluded from study participation.
- Subjects are able to understand the consent form and give written informed consent.
Who cannot join
- RECIPIENT
- Known sensitivity or contraindication to everolimus, tacrolimus, or psoralen.
- Aphakia.
- Has undergone splenectomy
- Patients with light-sensitive diseases including (but not limited to) systemic lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porhyria, xeroderma pigmentosum, and albinism
- Patient with significant or active infection.
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- Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
- Patients with PRA >80%
- Patients with current or historic donor specific antibodies
- Body Mass Index (BMI) of < 18 or > 40
- Patients who are pregnant or nursing mothers
- Patients whose life expectancy is severely limited by diseases other than renal disease
- Ongoing active substance abuse, drug or alcohol
- Major ongoing psychiatric illness or recent history of noncompliance
- Significant cardiovascular disease
- Malignancy within 3 years, excluding nonmelanoma skin cancers
- Subjects with cerebrovascular vascular disease with recent (< 6 months) stroke
- Serologic evidence of infection with HIV or HBVs Ag positive
- Recipient is EBV serologic negative
- Donor CMV serologic positive to recipient CMV serologic negative
- Recipient tests positive for HCV viral load by PCR
- Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet count < 100,000/mm3; triglyceride > 400 mg/dl; total cholesterol > 300 mg/dl
- Investigational drug within 30 days prior to transplant surgery
- Anti-T cell therapy within 30 days prior to transplant surgery
- Documented severe liver disease, defined as bridging fibrosis or cirrhosis on liver biopsy
- Poorly controlled diabetes, defined as HbA1c of > 8.0
- PT/INR > 2.0
- SBP < 90 or > 180mm Hg, HR > 120 or <50bpm, Temp > 99.5F on day of proposed ECP-DL procedure
- Patients receiving concomitant enteral or topical medical therapy with potentially photosensitizing effects
- DONOR
- Lack of possible peripheral IV access (two access sites)
- Has undergone splenectomy
- Donor tests positive for HCV viral load by PCR
- PT/INR > 2.0; or known hyper or hypo coagulable disorders
- Hgb < 10.0
- platelet count < 100,000
- SBP < 90 or > 160mm Hg, HR > 120 or <50bpm, Temp > 99.5F on day of proposed ECP-DL procedure
- Donors who cannot tolerate extracorporeal volume during PBMC collection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, Single Center Trial of Donor Extracorporeal Photopheresis (ECP) Treated Cell Infusion (ECP-DL) Plus Post-transplant ECP for the Prevention of Rejection in Living Donor Kidney Transplant Recipients
This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients. 2) Determine rates of graft rejection and compare to historical controls.
One week prior to planned LDK transplant the donor and recipient pair will be seen for ECP-DL preparation and infusion. Donors will undergo one single unstimulated peripheral blood mononuclear cell collection using the THERAKOS® CELLEX® Photopheresis System; the cell product will then undergo ECP treatment to make ECP-DL, which will then be infused into the recipient. One week later, recipients (n=12) will undergo LDK transplant using standard of care maintenance immunosuppression without antibody induction therapy. Subsequent patients will receive cell infusions in escalating cell doses. A minimum of two months will be used as an interval between ECP-DL treatment in each tier. A staggered approach for moving to the next tier will be employed waiting no less than two months to ensure absence of adverse events using the following tier dosing schema:
Read more
Tier 1: 0.5 x 10^9 ECP-DL treated cells (n=4) Tier 2: 1 x 10^9 ECP-DL treated cells (n=4) Tier 3: 2 x 10^9 ECP-DL treated cells (n=4)
Following transplant, LDK recipients will undergo ECP using the Therakos system on two consecutive days per month for 6 months (12 treatments). Peripheral IV access will be used whenever possible.
- Being tested
- ECP-DL treated mononuclear cell infusion
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECP-DL treated mononuclear cell infusionDevice
Participants in this study will undergo the infusion of donor white blood cells treated with ECP one week before their living donor kidney transplant, combined with standard of care antirejection medications. You will also then have ECP treatments using your own blood on two consecutive days once per month for 6 months. This combination is intended to cause your immune system to create a state called tolerance to the donor kidney. The ECP procedure has not been approved to prevent rejection after kidney transplant and the use of ECP to prevent rejection of transplanted organs is experimental, and is not a part of standard treatment which is based on the long term use of anti-rejection drugs such as tacrolimus (Prograf), everolimus, and prednisone.
| Study group | Role | What they receive |
|---|---|---|
| ECP-DL Cell Therapy Arm | Experimental | Participants will receive escalating doses of ECP-DL (extracorporeal photopheresis-derived dendritic-like) cells starting on Day -7 prior to living donor kidney transplantation. The intervention aims to evaluate the safety and immunomodulatory effects of ECP-DL cell infusion in the context of renal transplantation. Receives: Device: ECP-DL treated mononuclear cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events Following Escalating Doses of ECP-DL Cells
To determine the safety profile of escalating doses of ECP-DL cells administered to patients undergoing living donor kidney transplantation.
Measured: From Day -7 (first ECP-DL infusion) through 24 months post transplant
Secondary outcomes (5)
Incidence of Transplant-Related Adverse Events
To assess the frequency and type of adverse events associated with renal transplantation and immunosuppressive therapy.
Measured: Baseline through 24 months post-transplant.
Incidence and Severity of Infections
To evaluate the incidence, timing, and severity of bacterial, viral, and fungal infections post-transplant.
Measured: Baseline through 24 months post-transplant
Changes in Peripheral Blood Lymphocyte Subpopulations
To assess changes in lymphocyte subpopulations, including regulatory T cells and effector T cells, following ECP-DL infusion.
Measured: Baseline, Day 0, Day 7, Day 30, and Month 6
Change in Donor-Specific T Cell Response as Measured by Mixed Lymphocyte Reaction (MLR) and ELISPOT Assays
Donor-specific hyporesponsiveness will be assessed by measuring the proliferation of recipient peripheral blood mononuclear cells (PBMCs) in response to donor antigens using Mixed Lymphocyte Reaction (MLR), and by quantifying interferon-gamma (IFN-γ) producing cells using ELISPOT assays. Results will be reported as stimulation index (SI) for MLR and spot-forming units (SFU) per 10^6 PBMCs for ELISPOT.
Measured: Baseline, Day 30, and Month 6
Quantitative Changes in Plasma and Urine Proteins Identified by Mass Spectrometry-Based Proteomic Analysis
Blood and urine samples will be analyzed using mass spectrometry to measure changes in protein levels related to ECP-DL treatment and transplant outcomes. Protein levels will be reported using standard lab methods, and changes over time will be compared to identify significant differences.
Measured: Baseline, Day 30, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start30 Jan 2027 (estimated)
- Primary completion25 Dec 2029 (estimated)
- Study completion25 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Leventhal, Northwestern University
- Investigators
- Joseph Leventhal, MD, PhD, Principal investigator, Northwestern UniversityJennifer Schneiderman, MD, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083830
- Sponsor's protocol ID
- STU00222957
- Acronym
- ECP
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center Trial of Donor Extracorporeal Photopheresis (ECP) Treated Cell Infusion (ECP-DL) Plus Post-transplant ECP for the Prevention of Rejection in Living Donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07083830
- Acronym / sponsor ID
- ECP / STU00222957
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 25 Dec 2029 (estimated)
- Study completion
- 25 Dec 2029 (estimated)
- First posted
- 24 Jul 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.
This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients. 2) Determine rates of graft rejection and compare to historical controls.
One week prior to planned LDK transplant the donor and recipient pair will be seen for ECP-DL preparation and infusion. Donors will undergo one single unstimulated peripheral blood mononuclear cell collection using the THERAKOS® CELLEX® Photopheresis System; the cell product will then undergo ECP treatment to make ECP-DL, which will then be infused into the recipient. One week later, recipients (n=12) will undergo LDK transplant using standard of care maintenance immunosuppression without antibody induction therapy. Subsequent patients will receive cell infusions in escalating cell doses. A minimum of two months will be used as an interval between ECP-DL treatment in each tier. A staggered approach for moving to the next tier will be employed waiting no less than two months to ensure absence of adverse events using the following tier dosing schema:
Tier 1: 0.5 x 10^9 ECP-DL treated cells (n=4) Tier 2: 1 x 10^9 ECP-DL treated cells (n=4) Tier 3: 2 x 10^9 ECP-DL treated cells (n=4)
Following transplant, LDK recipients will undergo ECP using the Therakos system on two consecutive days per month for 6 months (12 treatments). Peripheral IV access will be used whenever possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECP-DL Cell Therapy Arm | Experimental | Device: ECP-DL treated mononuclear cell infusionParticipants will receive escalating doses of ECP-DL (extracorporeal photopheresis-derived dendritic-like) cells starting on Day -7 prior to living donor kidney transplantation. The intervention aims to evaluate the safety and immunomodulatory effects of ECP-DL cell infusion in the context of renal transplantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Recipient age ≥30 and less than 70 years old.
- Donor age ≥18 and ≤ 70 years old.
- Recipient of a first kidney transplant from a living unrelated or living related donor that is not HLA-identical to the donor.
- Donor willing to undergo cell collection for ECP-DL cell preparation and infusion.
- Donors will be screened and tested for HIV-1 (antigen and nucleic acid), HIV-2, hepatitis B virus (HBV, nucleic acid and surface and core antigen), hepatitis C virus (HCV, antigen and nucleic acid), Treponema pallidum (syphilis), West Nile Virus (WNV), and CJD (screening only). and tested for human T-lymphotropic virus types 1 and 2 (HTLV-1, HTLV-2) and CMV, in accordance with established UNOS guidelines for solid organ donors.
Key exclusion criteria (38 listed)
- RECIPIENT
- Known sensitivity or contraindication to everolimus, tacrolimus, or psoralen.
- Aphakia.
- Has undergone splenectomy
- Patients with light-sensitive diseases including (but not limited to) systemic lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porhyria, xeroderma pigmentosum, and albinism
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 |
|---|---|---|
| ECP-DL treated mononuclear cell infusionParticipants in this study will undergo the infusion of donor white blood cells treated with ECP one week before their living donor kidney transplant, combined with standard of care antirejection medications. You will also then have ECP treatments using your own blood on two consecutive days once per month for 6 months. This combination is intended to cause your immune system to create a state called tolerance to the donor kidney. The ECP procedure has not been approved to prevent rejection after kidney transplant and the use of ECP to prevent rejection of transplanted organs is experimental, and is not a part of standard treatment which is based on the long term use of anti-rejection drugs such as tacrolimus (Prograf), everolimus, and prednisone. | Device | ECP-DL Cell Therapy Arm |
Primary outcome
Incidence of Adverse Events Following Escalating Doses of ECP-DL Cells
Time frame: From Day -7 (first ECP-DL infusion) through 24 months post transplant
To determine the safety profile of escalating doses of ECP-DL cells administered to patients undergoing living donor kidney transplantation.
5 secondary outcomes
Incidence of Transplant-Related Adverse Events
Time frame: Baseline through 24 months post-transplant.
Incidence and Severity of Infections
Time frame: Baseline through 24 months post-transplant
Changes in Peripheral Blood Lymphocyte Subpopulations
Time frame: Baseline, Day 0, Day 7, Day 30, and Month 6
Change in Donor-Specific T Cell Response as Measured by Mixed Lymphocyte Reaction (MLR) and ELISPOT Assays
Time frame: Baseline, Day 30, and Month 6
Quantitative Changes in Plasma and Urine Proteins Identified by Mass Spectrometry-Based Proteomic Analysis
Time frame: Baseline, Day 30, and Month 6
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Joseph Leventhal, MD, PhD principal investigator
Northwestern University
Jennifer Schneiderman, MD, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ECP-DL treated mononuclear cell infusion in people with Kidney Transplant Failure and Rejection and Kidney Transplant; Complications, run by Northwestern University.
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 10 inclusion and 38 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Erica Cuasay (RN) (312-926-1076, erica.cuasay@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events Following Escalating Doses of ECP-DL Cells (time frame: From Day -7 (first ECP-DL infusion) through 24 months post transplant). 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 2 Nov 2026.