Can a new drug combo help kidney transplants last longer?

NCT ID NCT01729494

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

316 people

The number who actually took part.

Started

Sep 2012

Finished

Dec 2019

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 years and older

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: 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for End stage renal disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • California Pacific Medical Center

    San Francisco, California, 94107, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Denver

    Denver, Colorado, 80045, United States

  • University of Illinois Medical Center at Chicago

    Chicago, Illinois, 60612, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.