Could a simple shot replace monthly IV infusions for kidney transplant patients?
NCT ID NCT05975450
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at whether kidney transplant recipients can safely switch from monthly intravenous belatacept to weekly self-injected abatacept to prevent organ rejection. Sixteen adults who were 8-20 weeks post-transplant took part. Researchers checked how well patients could give themselves the shots, whether rejection occurred, and any serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Abatacept (Orencia) subcutaneous injection
- What this could lead to
- If it works, this could offer kidney transplant recipients a more convenient, self-administered option to prevent organ rejection.
- What could go wrong
- This is a very small, early-phase trial with only 16 participants, so results may not apply broadly. The switch could increase rejection risk or side effects.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Feb 2025
- 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
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18 to 70 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.
Inclusion Criteria: * Must be able to understand and provide informed consent. * Male or Female, 18-70 years of age at the time of enrollment (all races and ethnicities) * Negative crossmatch (virtual or physical) at the time of transplant * No less than 8 weeks, no more than 20 weeks post-transplant at enrollment * A first-time renal transplant who has been treated with belatacept from the time of transplant, receiving tacrolimus (target trough 3-5 ng/ml), mycophenolate mofetil (or mycophenolic acid or azathioprine), prednisone (also see exclusion criteria). * eGFR ≥ 40ml/min/m2 \[using 2021 the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\]. * Prior documented evidence of Epstein-Barr virus (EBV) seropositivity must be available. * Female study participants of childbearing potential must have a negative pregnancy test before enrollment. * Agreement to use contraception that is more than 80% effective. * Vaccines are current as per the Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials. * Study participants must have a negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved Interferon Gamma Release Assay (IGRA) blood test, such as QuantiFERON®-Gold tuberculosis (TB) or T-SPOT®-TB assay. PPD or IGRA testing must be documented to have been performed within the 52 weeks before enrollment. Patients with latent TB may become eligible after completion of treatment. Exclusion Criteria: * Inability or unwillingness of a study participant to give written informed consent or comply with the study protocol. * Recipient of previous organ transplant of any type. * Multi-organ transplant. * Calculated Panel Reactive Antibody (cPRA) \>80 at the time of enrollment. * History of any episode of biopsy-proven Banff rejection (including borderline rejection or any grade of acute TCMR) before enrollment. * History of any malignancy including lymphoma within 5 years of enrollment. Study participants with curatively treated non-melanomatous skin cancer or curatively treated cervical carcinoma in situ may be enrolled. * Any past or current issue which in the opinion of the investigator may pose additional risks to the participant in the study, may interfere with the study participant's ability to comply with the study requirements, or may impact the quality or interpretation of the data obtained from the study. * Human immunodeficiency virus (HIV): individuals known to be HIV positive. * Hepatitis C virus (HCV): any study participant who receives a kidney from a seropositive or HCV RNA PCR-positive donor is ineligible. Any study participant who was HCV RNA PCR positive at transplant is ineligible. Any study participant with a history of HCV seropositivity or HCV infection who has not met the criteria for sustained spontaneous clearance or sustained viral response to therapy is ineligible. * Hepatitis B virus (HBV): Individuals with any of the following are NOT eligible: * Recipient or donor positive for hepatitis B surface antigen (HBsAg) * Recipient or donor positive for antibodies to hepatitis B core antigen (anti-HBc) * Recipient or donor is known to have had a positive HBV DNA PCR * Evidence of CMV viremia or clinical CMV infection at any time after transplant. * Kidney recipients who were CMV seronegative who received an organ from a CMV seropositive donor. * BK viremia of greater than 4.3 DNA log copies/ml (greater than 20,000 copies/ml) at any time post-transplant. * Active uncontrolled infection within 1 month of enrollment. * Clinically significant proteinuria (urinary protein/Cr ratio \>1.0). * Receiving belatacept at a dose other than 5 mg/kg body weight. * Receiving mycophenolate mofetil at a dose of less than 1000 mg daily (or mycophenolic acid or azathioprine equivalent). * Receiving prednisone at a dose greater than 5 mg daily. * Presence of donor-specific antibody by Luminex single antigen bead assay.
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Genom att skicka in godkänner du våra Användarvillkor
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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Emory Clinic
Atlanta, Georgia, 30322, United States
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Emory Hospital
Atlanta, Georgia, 30322, United States
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