Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH

  • STATUS
    Recruiting
  • End date
    Jun 25, 2025
  • participants needed
    6
  • sponsor
    Massachusetts General Hospital
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Updated on 25 March 2022
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rituximab
prednisone
kidney transplant
dialysis
immunosuppression

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.

Details
Condition Renal Failure
Treatment Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Siplizumab, Combined bone marrow and kidney transplant
Clinical Study IdentifierNCT04540380
SponsorMassachusetts General Hospital
Last Modified on25 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female 18-60 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
Serologic evidence of prior exposure to EBV
Negative COVID at screening and 2 days before procedure

Exclusion Criteria

ABO blood group-incompatible renal allograft
Evidence of anti-HLA antibody (donor specific or not) within 60 days prior to transplant as assessed by routine methodology (Luminex)
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 other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
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 the irradiation component of the conditioning regimen
Enrollment in other investigational drug studies within 30 days prior to enrollment
Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT)
Allergy or sensitivity to any component of Siplizumab, Fludarabine, Cyclophosphamide tacrolimus, MMF or rituximab
The presence of any medical condition that the investigator deems incompatible with participation in the trial
Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c<7). Subject with severe retinopathy, gastroparesis, or severe neuropathy which prevent subject's normal independent daily activities will be excluded from the study
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