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Immunosuppressant
Abatacept Injections for Kidney Transplant Recipients (RTB-016 Trial)
Phase 1
Recruiting
Led By Idelberto R Badell, MD
Research Sponsored by Idelberto Badell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post transplant
Awards & highlights
No Placebo-Only Group
Summary
This trial is researching if weekly injections of abatacept are an effective substitute for monthly IV infusions of belatacept to prevent transplant rejection. It may also allow greater flexibility for patients when traveling.
Who is the study for?
This trial is for kidney transplant recipients aged 18-70 with stable kidney function (eGFR ≥ 40ml/min/m2), who have been treated with belatacept post-transplant and are EBV positive. Participants must agree to use effective contraception, be up-to-date on vaccines, and test negative for TB. Exclusions include high-dose prednisone users, previous organ transplants, certain cancer histories, active infections including HIV/HBV/HCV/CMV/BK virus, uncontrolled proteinuria or donor-specific antibodies.
What is being tested?
The study tests if weekly self-administered abatacept injections can replace monthly belatacept IV infusions in preventing kidney rejection after a transplant. It aims to determine the safety and effectiveness of abatacept as well as its impact on kidney function compared to the standard treatment.
What are the potential side effects?
Potential side effects of abatacept may include increased risk of infections due to immune system suppression, possible allergic reactions at injection sites, fatigue, headache or nausea. As it's an immunosuppressive drug used post-transplantation; close monitoring for any adverse effects is crucial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of any malignancy
Incidence of patients with BK viremia stratified by the magnitude
Incidence of patients with cytomegalovirus (CMV) viremia stratified by the magnitude
+4 moreSecondary study objectives
Change in estimated GFR (eGFR)
Number of days to events [TCMR, ABMR, de-novo specific antibodies (DSA) formation, graft loss].
Number of subjects treated for acute rejection due to clinical suspicion rather than BP-aTCMR or BP-aABMR within 12 months of transplantation.
+7 moreSide effects data
From 2016 Phase 4 trial • 3 Patients • NCT0207819367%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AbataceptExperimental Treatment1 Intervention
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
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Who is running the clinical trial?
Idelberto BadellLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,392,746 Total Patients Enrolled
Idelberto R Badell, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
87 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have hepatitis B as indicated by negative tests for HBsAg, anti-HBc, and HBV DNA PCR.I have tested positive for the Epstein-Barr virus in the past.My vaccines are current according to transplant trial guidelines.I have not had any serious infections in the last month.I am between 18 and 70 years old.I had my transplant between 8 and 20 weeks ago.I have had a biopsy showing rejection of a transplanted organ before.I have had CMV infection or virus presence in my blood after a transplant.I have tested negative for tuberculosis within the last year.I am taking belatacept at a dose different from 5 mg/kg.I am taking less than 1000 mg daily of mycophenolate mofetil or its equivalent.I have not had cancer, except for certain skin or cervical cancers, in the last 5 years.I have received transplants for more than one organ.I received a kidney from a donor who had CMV, but I did not have CMV before the transplant.I have never had Hepatitis C or received a kidney from someone with Hepatitis C.I am taking more than 5 mg of prednisone daily.I am a woman able to have children and have a negative pregnancy test.I received a kidney transplant and have been on belatacept, tacrolimus, mycophenolate (or similar), and prednisone since then.
Research Study Groups:
This trial has the following groups:- Group 1: Abatacept
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.