NCT05900401 Delayed Tolerance Through Mixed Chimerism
| NCT ID | NCT05900401 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Kidney Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2031-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-10-01 with a primary completion date of 2031-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased donor). An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
Eligibility Criteria
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.
Contact & Investigator
Tatsuo Kawai
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05900401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Kidney Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05900401 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05900401 currently recruiting?
Yes, NCT05900401 is actively recruiting participants. Contact the research team at tkawai@mgh.harvard.edu for enrollment information.
Where is the NCT05900401 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05900401 clinical trial?
NCT05900401 is sponsored by Massachusetts General Hospital. The principal investigator is Tatsuo Kawai at Massachusetts General Hospital. The trial plans to enroll 20 participants.
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