Can a new drug let kidney transplant patients skip steroids and CNIs?
NCT ID NCT01436305
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers are testing whether belatacept can protect a new kidney while avoiding two standard anti-rejection medicines: calcineurin inhibitors and steroids. These standard drugs help prevent rejection but can cause serious long-term side effects, including kidney damage. The trial enrolls adults receiving their first kidney transplant and gives them belatacept along with other immune-suppressing drugs. The goal is to see how well the new kidney works after one year and whether rejection occurs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belatacept, an anti-rejection drug for kidney transplant patients
- What this could lead to
- If it works, kidney transplant patients might avoid daily steroids and calcineurin inhibitors, which can damage kidneys and cause other serious problems over time.
- What could go wrong
- This is a small Phase 2 trial with only 19 participants, so results may not hold in larger groups. Belatacept carries a risk of serious infections and post-transplant lymphoproliferative disorder, a type of cancer.
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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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19 people
The number who actually took part.
- Start date
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Sep 2011
- Finished
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Apr 2015
- 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 a 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; * Female and male participants with reproductive potential must agree to use FDA approved methods of birth control during participation in the study and for 4 months following completion of the study; * Flow-based PRA within last 12 months (in absence of a sensitizing event) of \< 30% as determined by each participating study center. If the subject experienced a sensitizing event after the PRA test date, then the PRA must be repeated and confirmed \<30%; * Negative crossmatch or a PRA of 0% on historic and admission sera as determined by each participating study center. * A documented negative TB test within the 12 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; * EBV sero-negative (or unknown) recipients; * Active infection including hepatitis B, hepatitis C, or 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; * HLA identical living donors; * Individuals at significant risk of early recurrence of the primary renal disease including FSGS and 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; * Individuals previously treated with NULOJIX® (belatacept); * 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.
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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
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 cocktail keep kidney transplants healthy without steroids or tacrolimus?