Can a new drug cocktail keep kidney transplants healthy without steroids or tacrolimus?
NCT ID NCT01856257
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers are testing whether a belatacept-based regimen can protect a transplanted kidney without using standard anti-rejection drugs called calcineurin inhibitors and corticosteroids. The trial enrolls adults receiving their first kidney transplant. Participants receive belatacept along with anti-thymocyte globulin and a short course of methylprednisolone. The goal is to see if this approach improves long-term kidney function without increasing the risk of rejection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belatacept, given with anti-thymocyte globulin and a short course of methylprednisolone
- What this could lead to
- If it works, this could offer kidney transplant recipients a way to keep their new organ healthy without standard anti-rejection drugs that can harm the kidneys over time.
- What could go wrong
- This is a small Phase 2 trial, so results may not hold in larger studies. Avoiding standard drugs might raise the risk of organ rejection, and belatacept carries its own risks.
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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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71 people
The number who actually took part.
- Start date
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Jul 2013
- Finished
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Apr 2016
- 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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18 to 65 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: * Male or Female, 18-65 years of age at the time of enrollment; * Ability to understand and provide written informed consent; * Candidate for primary renal allograft from either living or deceased donor; * No known contraindications to study therapy using NULOJIX® (belatacept); * Female participants of childbearing potential must have a negative pregnancy test upon study entry; * Participants with reproductive potential must agree to use an appropriate method(s) of birth control as outlined in the CellCept® , Myfortic® or generic package labeling during participation in the study and for 4 months following completion of the study; * No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator; * Negative crossmatch or Panel Reactive Antibodies (PRA) of 0% on historic and current sera, as determined by each participating study center; * A documented negative tuberculosis (TB) test within the 6 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed. Exclusion Criteria: * Need for multi-organ transplant; * Recipient of previous organ transplant; * Epstein-Barr Virus (EBV) seronegative (or unknown) recipients; * Active infection including hepatitis B, hepatitis C, or human Immunodeficiency Virus (HIV); * Individuals who have required treatment with prednisone or other immunosuppressive drugs within 1 year prior to transplant; * Individuals undergoing transplant using organs from extended criteria donor (ECD) or donation after cardiac death (DCD) donors; * Histocompatibility antigen (HLA) identical living donors; * Individuals at significant risk of early recurrence of the primary renal disease including focal segmental glomerulosclerosis (FSGS) and membranoproliferative glomerulonephritis (MPGN) type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function; * Known history of thrombotic events or risk factors, including any of the following: * Factor V Leiden, elevated homocysteine, positive lupus anticoagulant, elevated anticardiolipin antibody, heparin-induced thrombocytopenia, * A family history of a heritable thrombotic condition, * Recurrent deep vein thrombosis (DVT) or pulmonary emboli (PE), * Unexplained stillborn infant or recurrent spontaneous abortion or other congenital or acquired thrombotic disorder. At the discretion of the investigator, a history of thrombosis of a dialysis access graft, fistula, or indwelling catheter/device may not be considered an exclusion criterion. * Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements; * Use of investigational drugs within 4 weeks of enrollment; * Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components; * Administration of live attenuated vaccine(s) within 8 weeks of enrollment; * Blood type A2 and A2B donors into blood type B recipients.
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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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Emory University
Atlanta, Georgia, 30322, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The rare transplant patients who quit Anti-Rejection drugs: can a blood test find others like them?
- Can a blood test catch kidney rejection before damage sets in?
- Urine test may replace biopsies for kidney transplant patients
- Can a donor Organ's gene signature foretell rejection?
- Can simple tests replace biopsies for kidney transplant patients?
- Can a new drug let kidney transplant patients skip steroids and CNIs?