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Abatacept Conversion for Kidney Transplant Recipients
Study Summary
This trial is testing whether patients can safely switch from monthly IV infusions of belatacept to subcutaneous injections of abatacept without a decrease in kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 613 Patients • NCT03086343Trial Design
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- I am taking belatacept, but not at a 5 mg/kg dose.I am taking less than 1000 mg of mycophenolate mofetil or its equivalent daily.I have been taking more than 5 mg of prednisone daily in the last 3 months.I haven't had any organ rejection episodes in the last 6 months.I have had a CMV infection or virus presence in the last 3 months.I have a high level of specific antibodies against a donor.You have a history of substance abuse or a mental health condition that may make it difficult for you to follow the study instructions and attend follow-up appointments.I am 18 years old or older.I am receiving my first kidney transplant.I've had more than one serious rejection episode after a transplant.I have not taken antibiotics or antivirals in the last month.My kidney function is low (GFR below 35).I am not on prednisone for long-term immune system suppression.I have been treated with belatacept since my transplant.This is my first organ transplant.My immune system has low reactivity to certain transplant markers.I have had more than one kidney transplant or received multiple organ transplants.I have untreated latent tuberculosis.I have had only one major rejection episode after my transplant.I am on specific immune-suppressing medications.I had a transplant over 2 years ago and stopped CNI therapy more than 6 months ago.You have a low risk of immune system problems.
- Group 1: Abatacept Group (Conversion Group)
- Group 2: Belatacept group (Control Group)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What is the governmental regulation surrounding Abatacept?
"Abatacept has not been proven effective yet, but there is data supporting its safety which earns it a score of 2."
Why is Abatacept often recommended as a treatment?
"Abatacept is not only useful for treating steroid therapy, but also rheumatoid arthritis, rejection; transplant, kidney, and psoriatic arthritis."
Is this the first time Abatacept has been studied?
"There are Abatacept clinical trials ongoing. Out of these, 9 are in Phase 3. The largest concentration of research is occurring in Durham, North carolina; however, there are a total 823 sites running studies for Abatacept."
Are there any available appointments for this clinical trial?
"This trial is currently seeking patients, as reported on clinicaltrials.gov. The trial was originally posted on 9/22/2021 and was most recently updated on 9/29/2022."
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