Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH
United States20 participantsStarted 2021-09-01
Plain-language summary
The goal is to investigate the safety of the conditioning regimen, and its ability to induce donor/recipient lymphohematopoietic chimerism without Chimerism Transition Syndrome (CTS), which may result in donor-specific unresponsiveness (tolerance) to the renal allograft in the absence of maintenance immunosuppression.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female 18-65 years of age.
* Candidate for a living-donor renal allograft from an HLA mismatched donor
* Subjects with chronic kidney disease stage or ESRD who are treated with either hemodialysis or peritoneal dialysis.
* First transplant.
* Use of FDA-approved methods of contraception
* Ability to understand and provide informed consent.
* Negative COVID at screening and 2 days before procedure
Exclusion Criteria:
* ABO blood group-incompatible renal allograft.
* Participant with a (non DSA) PRA \> 20% within 6 months prior to transplant
* Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3).
* Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
* Active infection
* Left ventricular ejection fraction \< 40% as determined by TTE or clinical evidence of heart failure
* Forced expiratory volume FEV1 or DLCO \< 50% of predicted.
* Lactation or pregnancy
* History of cancer (following the American Transplant Society Guidelines)
* Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis).
* Prior dose-limiting radiation therapy
* Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Transient Chimerism
Timeframe: 36 months after immunosuppression withdrawal
2
Incidence of Chimerism Transition Syndrome
Timeframe: 36 months after immunosuppression withdrawal
3
Incidence of tolerance induction
Timeframe: 36 months after immunosuppression withdrawal