Kidney transplant breakthrough: could this be the end of lifelong pills?
NCT ID NCT03504241
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new approach to help kidney transplant recipients stop taking anti-rejection drugs. Eight adults received donor stem cells along with a special mix of medications to see if their bodies would accept the new kidney without needing lifelong drugs. The goal was to safely reduce and possibly eliminate all anti-rejection medicine, but long-term success was not guaranteed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Sep 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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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19 years and older
- 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.
Inclusion Criteria: Recipient: * Adult candidates of an human leukocyte antigen (HLA)-non-identical, living-donor kidney transplant: --Candidates must meet the United Network for Organ Sharing (UNOS) criteria, including laboratory criteria, for transplant listing; * Evidence of established immunity to Epstein-Barr Virus (EBV) as demonstrated by serologic testing; * Serological evidence of prior Cytomegalovirus (CMV) infection if donor is CMV positive; * For women of child bearing potential: * A negative serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of start of study medication; and * Agreement to use contraception: \--- According to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective ----Female recipients of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for 18 months after the first dose of study therapy. Donor: * Meets institutional selection criteria for organ and bone marrow donation: --All donors will be screened and tested in accordance with: * (i) FDA 21 CRF 1271.85 requirements for donors of human cells, tissues, and cellular- and tissue-based products (HCT/P); and * (ii) standards for living kidney donors testing for infection established by the United Network for Organ Sharing (UNOS). * Ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvest. Exclusion Criteria: Recipient: * History of any immunodeficiency syndrome (including Human Immunodeficiency Virus-1 (HIV-1) and HIV-2); * Positive anti-Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR), anti-Hepatitis C Virus (HBV) PCR, or HBV surface antigen; * History of malignancy within 5 years of enrollment or any history of hematogenous malignancy or lymphoma; --Exception: Participants with curatively treated non-melanomatous skin cancer or curatively treated cervical carcinoma in situ may be enrolled. * Underlying renal disease with high likelihood of recurrence, including but not limited to: * primary focal segmental glomerulosclerosis (FSGS), * Type I or II membranoproliferative glomerulonephritis (MPGN), * hemolytic-uremic syndrome and * thrombotic thrombocytopenic purpura (HUS/TTP) syndrome. ---Subject(s) with end-stage renal disease (ESRD) of unknown etiology and/or has no histologically confirmed diagnosis, may be enrolled into the study as long as there are no clinical signs or symptoms consistent with excluded clinical diagnoses. * History of active M. tuberculosis: --Participants with a history of latent M. tuberculosis (LTB) as defined by positive testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON®-Gold TB or T-SPOT-TB assay must: * have completed treatment for LTB and * have a negative chest x-ray. ----All participants will undergo IGRA testing for M tuberculosis within 3 months prior to transplant. * Current or historical evidence of donor-specific antibody; * Immunosuppressive drug therapy within one year prior to enrollment. * May not be taking or have taken prednisone, cyclosporine A, tacrolimus, azathioprine, Mycophenolate Mofetil (MMF), cyclophosphamide, methotrexate, infliximab, etanercept, or other agents which have a primary therapeutic effect of immunosuppression in the year prior to transplantation. * May not have taken depletional anti-lymphocyte agents at any time. ---Exceptions: * Short (≤ 30 days) courses of topical or inhaled steroids are permitted, as are * Short oral or parental pulses for a documented hypersensitivity reaction. * Active autoimmune disease requiring ongoing immunosuppressive therapy or other conditions in which there is an anticipated need for immunosuppressive maintenance therapy; * Uncompensated congestive heart failure, pulmonary edema, or symptomatic pulmonary hypertension; * Active severe infection within a month of the screening visit; * Use of an investigational drug within 30 days of the screening visit; * Presence of any medical condition that the investigator deems incompatible with trial participation; or * Inability or unwillingness to comply with protocol monitoring and therapy. Donor: * History of blood donation to the recipient; * Evidence of prior Cytomegalovirus (CMV) infection if the recipient is CMV negative; * History of HIV-1/HIV-2 infection; * Positive HCV PCR, HBV PCR or HBV surface antigen;or * Presence of any medical condition that the investigator deems incompatible with trial participation.
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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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Duke University Health System
Durham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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