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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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, DMSO, 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Tatsuo Kawai, MD, PhD
617-726-0289
tkawai@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Tatsuo Kawai, MD PhD
617-726-0289
tkawai@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.