Could a bone marrow transplant free kidney patients from lifelong pills?
NCT ID NCT06972069
First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times
Summary
This early-phase trial tests a combined kidney and bone marrow transplant from the same donor to help the body accept the new kidney without needing lifelong anti-rejection drugs. Up to 12 adults with kidney failure will receive the treatment. The goal is to see if this approach can safely reduce or eliminate the need for daily immunosuppression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combined kidney and bone marrow transplant with siplizumab, rituximab, tegoprubart, and low-dose cyclophosphamide
- What this could lead to
- If successful, this could allow kidney transplant recipients to stop or greatly reduce their lifelong anti-rejection medications.
- What could go wrong
- This is a very early, small trial with only 12 participants. The approach carries risks like graft rejection, infection, and a rare complication called chimeric transition syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- 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. Subjects with chronic kidney disease stage V (GFR\<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis. 3. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor 4. First or second renal transplant. 5. EBV Seropositive 6. Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation 7. Ability to understand and provide informed consent. 8. Negative COVID-19 test during screening and two days prior to procedure Recipient Exclusion Criteria: 1. ABO blood group-incompatible renal allograft 2. Participant with a donor-specific antibody (DSA) within 6 months prior to transplant 3. Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3) 4. 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. 5. Untreated Infection 6. Left ventricular ejection fraction \< 40% as determined by TTE or clinical evidence of heart failure. 7. Forced expiratory volume FEV1 or DLCO \< 50% of predicted. 8. Lactation or pregnancy. 9. Patients with active cancer or those with a high risk of recurrence following the American Transplant Society 10. Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as non-genetic primary focal segmental glomerulosclerosis dense deposit disease, C3 glomerulonephritis, and, atypical hemolytic uremic syndrome). 11. Prior dose-limiting radiation therapy for treatment of malignant disease. 12. 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. This includes long term cigarette smoking or a family history of malignancy. 13. Enrollment in other investigational drug studies within 30 days prior to enrollment. 14. 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. 15. Allergy or sensitivity to any component of Cyclophosphamide, ATGAM, tacrolimus, Siplizumab, Tegoprubart, or rituximab. 16. The presence of 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. 17. Any chronic or intermittent administration of immunosuppressant medication (such as for inflammatory bowel disease or asthma) 18. Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\<8%). Subjects with severe diabetes-related complications, such as advanced retinopathy, gastroparesis, or severe neuropathy that significantly impair their ability to perform normal, independent daily activities, will also be excluded. Donor Inclusion Criteria: 1. Male or female 18-70 years of age. 2. For females of childbearing potential: a serum pregnancy test showing negative results. 3. Excellent health per conventional pre-donor workup (medical and psychosocial evaluation) 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 HBV (HbsAg and NAT), HIV (antibody and NAT), HCV (NAT), 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 bone marrow aspiration and kidney donation. 9. Negative COVID-19 test during screening and two days prior to procedure
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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