Could a bone marrow transplant free kidney patients from lifelong drugs?
NCT ID NCT05900401
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a bone marrow transplant, given after a kidney transplant, can help the body accept the new kidney without needing lifelong anti-rejection drugs. About 20 adults aged 18-65 who already have a well-functioning kidney transplant will receive an investigational medication and other treatments to protect the kidney. The goal is to see if this approach is safe and can lead to long-term kidney tolerance.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Recipient Inclusion Criteria 1. Male or female 18-65 years of age. 2. Kidney transplant recipients from either LD or DD, with cryo-preserved HSCs available, good renal function (GFR\>60 ml/min/1.73m2), normal current allograft biopsy, and no history of documented rejection episodes. 3. First or second renal transplant. 4. Use of FDA-approved methods of contraception (those with less than a 3% failure rate) by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation. (For further information on FDA- approved methods of contraception, see https://www.fda.gov/media/150299/download 5. Ability to understand and provide informed consent. 6. Negative COVID-19 test during screening and two days prior to HSC transplantation (HSCT). Deceased Donor (DD) 1. Male or female 18-70 years of age. 2. Consent to donate vertebral bones is obtained from the donor family. 3. HSCs are successfully cryopreserved and saved \>2X106/kg (CD34+ cells) of the recipient. 4. Acceptable laboratory parameters (hematology in normal or near-normal range. Liver function \<2 times the upper limit of normal, and normal creatinine) 5. Negative for viral infection with HbsAg, HIV, HCV, or HTLV-1 6. Negative COVID-19 test at the time of HSC procurement. Living Donor (LD) 1. Willingness to provide HSCs by leukapheresis or bone marrow aspiration. 2. Negative serologic pregnancy test for females of childbearing potential 3. Good general health as per conventional evaluation for kidney donation. 4. Acceptable laboratory parameters (hematology in normal or near normal range. Liver function \<2 times the upper limit of normal, and normal creatinine) 5. Negative for viral infection with HbsAg, HIV, HCV, or HTLV-1. 6. Cardiac/pulmonary function within normal limits (CXR, ECG). 7. Ability to understand and provide informed consent. 8. Meets standard institutional criteria for PBSC collection. 9. Negative COVID-19 test during screening and two days prior to PBSC collection. Recipient Exclusion Criteria 1. ABO blood group-incompatible renal allograft. 2. Evidence of anti-HLA antibody (donor specific with an MFI \>1000) as assessed by routine methodology (Luminex) 3. Previous history of biopsy proven rejection. 4. Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3). 5. Seropositivity for HIV-1, hepatitis B surface or core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA). 6. Active infection 7. Left ventricular ejection fraction \< 40% as determined by TTE or clinical evidence of heart failure. 8. Forced expiratory volume FEV1 or DLCO \< 50% of predicted. 9. Lactation or pregnancy. 10. History of cancer (following the American Transplant Society Guidelines) 11. Underlying renal disease etiology with high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis). Autoimmune diseases such as Lupus and Thrombotic Thrombocytopenic Purpura. 12. Enrollment in other investigational drug studies within 30 days prior to enrollment. 13. Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT), or any patients on chronic anticoagulation therapy. 14. Allergy or sensitivity to any component of Siplizumab, fludarabine, CP, tacrolimus, MMF or rituximab. 15. Any medical condition that the investigator deems incompatible with participation in the trial. This includes a history of alcohol abuse or illicit drug use/dependence. 16. Non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\<7). Severe retinopathy, gastroparesis, or severe neuropathy which prevent subject's normal independent daily activities.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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