Can a new drug combo help kidney transplants last longer?
NCT ID NCT01729494
First seen Jul 24, 2026 ยท Last updated Jul 24, 2026
Summary
This trial tests whether a belatacept-based immunosuppressive regimen, combined with either alemtuzumab or rabbit antithymocyte globulin (rATG) and early steroid withdrawal, can reduce the risk of graft loss, death, or poor kidney function after a kidney transplant. The study compares these approaches to a standard tacrolimus-based regimen with rATG induction. Participants are adults receiving a kidney from a living or deceased donor. The goal is to find a safer and more effective way to prevent organ rejection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of belatacept, alemtuzumab, rabbit antithymocyte globulin, and mycophenolate mofetil
- What this could lead to
- If successful, this could point toward a safer, more effective immunosuppression strategy for kidney transplant recipients, reducing the risk of graft loss and improving kidney function.
- What could go wrong
- This is a phase 4 trial comparing multiple drug regimens, so results may not show clear superiority. The treatments carry risks of infection and other side effects from immunosuppression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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316 people
The number who actually took part.
- Started
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Sep 2012
- Finished
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Dec 2019
- 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: 1. Male and female patients \> 18 years of age. 2. Patient who is receiving a renal transplant from a living or deceased donor. 3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion. 4. The patient has given written informed consent to participate in the study. Exclusion Criteria: 1. Patient has previously received an organ transplant other than a kidney. 2. Patient is receiving an human leucocyte antigen (HLA) identical living donor transplant. 3. Patient who is a recipient of a multiple organ transplant. 4. Patient has a most recent cytotoxic panel reactive antibody (PRA) of \>25% or calculated PRA of \> 50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization. 5. Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies. 6. Patient with a donor specific antibody (DSA) as deemed by the local PI to be associated with significant risk of rejection. 7. Patient has received a blood group (ABO) incompatible donor kidney. 8. The donor and/or donor kidney meet any of the following extended criteria for organ donation (ECD): * Donor age \>/= 60 years OR * Donor age 50-59 years and 1 of the following: * Cerebrovascular accident (CVA) + hypertension + serum creatinine (SCr) \> 1.5 mg/dL OR * CVA + hypertension OR * CVA + SCr \> 1.5 mg/dL OR * Hypertension + SCr \> 1.5 mg/dL OR * Cold ischemia time (CIT) \> 24 hours, donor age \> 10 years OR * Donation after cardiac death (DCD) 9. Recipients will be receiving a dual or en bloc kidney transplant. 10. Donor anticipated cold ischemia is \> 30 hours. 11. Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C viral load are excluded. HCV seropositive patients with a negative HCV viral load testing may be included. 12. Recipients who are Hepatitis B core antibody seropositive are eligible if their hepatitis B viral loads are negative. After transplant, their hepatitis B viral loads will be monitored every three months for the first year after transplant. If hepatitis B viral loads become positive, patients will be treated per institutional standard of care. 13. Patients who are Hepatitis B surface antibody seropositive and who receive a kidney from a Hepatitis B core surface antibody positive donor may be included. 14. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV). 15. Recipient who is seronegative for Epstein Barr virus (EBV). 16. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives. 17. Patients with thrombocytopenia (PLT \< 75,000/mm3), and/or leucopoenia (WBC \< 2,000/mm3), or anemia (hemoglobin \< 6 g/dL) prior to study inclusion. 18. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant. 19. Patient who has undergone desensitization therapy within 6 months prior to transplant. 20. Patient has a known hypersensitivity to belatacept, tacrolimus, mycophenolate mofetil, alemtuzumab, rabbit anti-thymocyte globulin, or glucocorticoids. 21. Patient is receiving chronic steroid therapy at the time of transplant. 22. Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years, unless they have an expected disease free survival of \> 95%. 23. Patient is pregnant, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test. 24. Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. 25. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator. 26. Inability to cooperate or communicate with the investigator.
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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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California Pacific Medical Center
San Francisco, California, 94107, United States
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Tampa General Hospital
Tampa, Florida, 33606, United States
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The Christ Hospital
Cincinnati, Ohio, 45219, United States
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University of Cincinnati
Cincinnati, Ohio, 45219, United States
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University of Colorado Denver
Denver, Colorado, 80045, United States
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University of Illinois Medical Center at Chicago
Chicago, Illinois, 60612, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
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