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Could a simple shot replace monthly IV infusions for kidney transplant patients?

NCT ID NCT05975450

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Aug 2023

Finished

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

18 to 70 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.

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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Emory Hospital

    Atlanta, Georgia, 30322, United States

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