Kidney transplant patients may swap monthly IV for weekly shots in new study
NCT ID NCT04955366
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether kidney transplant patients can safely switch from monthly belatacept IV infusions to weekly abatacept injections without losing kidney function. The study enrolls 87 low-risk adults who are at least two years post-transplant. Researchers will compare kidney function between the two groups over 12 months.
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) and belatacept (Nulojix), both immunosuppressive drugs
- What this could lead to
- If successful, this could offer kidney transplant patients a more convenient at-home injection option instead of monthly IV infusions, while maintaining kidney function.
- What could go wrong
- This is a small, early-phase (2b) study at a single center, so results may not apply broadly. Switching drugs could still lead to kidney function decline or rejection, and both drugs suppress the immune system, raising infection risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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87 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Jun 2026
- Lead sponsor
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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 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: Individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. Adult (age ≥18 years currently) 2. First-time renal transplant recipients of either living donor or deceased donor 1. Treatment with belatacept from the time of transplant 2. At least 2 years post-transplant and off CNI therapy for at least 6 months 3. Patients at low immunologic risk 1. First time transplant 2. HLA antibody screen with PRA \< 80% against class I and class II antigens 3. Negative crossmatch (actual or virtual) 4. No donor specific anti-HLA antibody (DSA) 5. No more than one episode of rejection (Banff grade 1A or greater) 6. No episodes of rejection (borderline or greater) within the last 6 months prior to study participation 7. No rejection of Banff grade IIB or greater 4. Immunosuppression consisting of belatacept (5mg/kg q 1M), mycophenolate mofetil (at least 1000 mg daily), or equivalent mycophenolic acid (720 mg daily) or azathioprine (1- 2 mg/kg daily) dose, and prednisone 5 mg daily. 5. Confirmed Tb screening at the time of transplantation Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrollment as study participants: 1. Repeat renal transplant, or multi-organ transplant recipient 2. History of more than one episode of biopsy-proven acute rejection (Banff grade 1A or greater), or of any episode of rejection of Banff 97 grade IIB or greater, or any rejection (borderline or greater) within the last 6 months 3. Pregnancy (women of childbearing potential must use adequate contraception during study) 4. GFR less than 35 5. Serum creatinine at enrollment more than 30% higher than at 3 months (±4 weeks) prior to randomization 6. Recent history of clinically significant proteinuria (urinary protein/Cr ratio \>1.0) 7. Receiving belatacept at a dose other than 5 mg/kg body weight 8. Receiving mycophenolate mofetil at a dose of less than 1000 mg po QD (or mycophenolic acid or azathioprine equivalent). 9. Receiving prednisone at a dose greater than 5 mg po qd within 3 months of enrollment 10. Not currently receiving maintenance immunosuppression with prednisone 11. Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization 12. Evidence of CMV viremia or clinical CMV infection within the last 3 months prior to randomization. 13. BK viremia of greater than 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization 14. Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required) 15. Known HIV-positivity (testing not required) 16. Presence of donor specific antibody by Luminex single antigen bead assay, or antibody screen (% PRA) above 80%. 17. History of substance abuse or psychiatric disorder not compatible with study adherence and follow up. 18. History of medical noncompliance 19. Untreated latent Tb (as determined from prior Tb screening at the time of transplantation)
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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
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Emory University Hospital (EUH)
Atlanta, Georgia, 30322, United States
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