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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

RTB-016 Trial 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.Check my eligibility
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.See study design
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.

RTB-016 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193
67%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept

RTB-016 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.

Find a Location

Who is running the clinical trial?

Idelberto BadellLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,219 Total Patients Enrolled
Idelberto R Badell, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Abatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05975450 — Phase 1
Kidney Transplant Recipients Research Study Groups: Abatacept
Kidney Transplant Recipients Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT05975450 — Phase 1
Abatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975450 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to adults of all ages, including those over 35 years old?

"The upper and lower bounds for eligibility in this trial are 18 and 70 years of age respectively, as specified by the inclusion criteria."

Answered by AI

Are volunteers still being accepted into this experiment?

"As indicated on clinicaltrials.gov, this research is not presently recruiting participants. The study was initially announced in September of 2023 and last updated August 2nd of the same year. Despite that, there are 16 other trials actively looking for volunteers at this time."

Answered by AI

Has Abatacept obtained regulatory approval from the FDA?

"Abatacept's safety is quantified with a score of 1 as it is currently in Phase 1 trials, thus there are limited reliable studies that support its efficacy and security."

Answered by AI

Could I potentially qualify for participation in this investigation?

"Eligibility criteria for this trial includes having undergone a kidney transplant and being aged between 18-70 years old. At present, the study is seeking to recruit 18 participants in total."

Answered by AI

What impact is the research team hoping to make with this investigation?

"The central objective of this medical study, which is monitored over a 12-month period, is ascertaining the proportion of participants who manage to stay free from acute T-cell mediated rejection (AaTCMR) or antibody-mediated rejection (ABMR), as defined by Banff criteria. Additional secondary objectives include determining the incidence of BP-aTCMR and tracking how many patients are treated for any type of rejection within 12 months post transplantation, including those that receive treatment based on clinical suspicion alone."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Subcutaneous Abatacept in Renal Transplant Recipients
Idelberto Badell 2023. "Subcutaneous Abatacept in Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05975450.
~8 spots leftby Dec 2024
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