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Could a bone marrow transplant free kidney patients from lifelong drugs?

NCT ID NCT05900401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.