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Belatacept Regimen for Kidney Transplant Recipients
Study Summary
This trial is testing whether it's better for teens with kidney transplants to switch to a different immunosuppressive drug regimen.
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.Trial Design
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- I've been on a stable medication regimen for my condition for at least 30 days.I received a kidney transplant more than 6 months ago.I have been treated for acute rejection of a transplant within the last 6 months.I have had a severe rejection episode with my current organ transplant.My kidney function has been stable for the last 3 months.I completed my initial COVID-19 vaccination series at least 6 weeks ago.I have been exposed to EBV in the past but currently show no signs of EBV replication.I have been treated with belatacept or was in a belatacept trial with my current transplant.I am between 12 and 17 years old.My current transplant is experiencing rejection confirmed by a biopsy.I have or had untreated or active TB.
- Group 1: Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap
- Group 2: Arm 2: Continue calcineurin inhibitor-based regimen
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many people fit the qualifications for this clinical trial?
"Yes, an active search for participants is underway according to the listing on clinicaltrials.gov. This study was first made public on 7/21/2021 and updated most recently on 10/24/2022. 1 trial site is looking for 102 individuals to take part in the research."
Would this research be appropriate for someone who is a senior citizen?
"This particular trial is for minors that 12 to 17 years old, however, there are many other options available both for children and adults. In total, 86 trials are meant for patients below 18 years old while 209 trials focus on individuals that are 65 or older."
To whom is this research opportunity available?
"Adolescents, aged 12 to 17, who have received a renal allograft in the last 6 months and currently stable are eligible for this trial. In order to be selected, patients must also meet the following conditions: Must have been on a regimen of calcineurin inhibitors (CNI) with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization, Have had clinically stable renal function during the"
Has the FDA given its okay to shift patients from one drug (CNI) to another (belatacept) after a brief period of using both?
"Arm 1 of this Phase 3 clinical trial, which looks at the safety of conversion from a CNI- to belatacept-based regimen after a period of overlap, is estimated to be safe."
Why do some patients need to take a combination of belatacept and CNI drugs?
"Arm 1: The administration of belatacept after a period of overlap is used to convert patients from a CNI-based regimen. This treatment can help prevent stem cell transplant rejection and manage other conditions like interstitial cystitis, nephrotic syndrome, and bone marrow transplantation."
Are patients still being accepted for this experiment?
"According to the official website, this clinical trial is still looking for participants. The original posting was on July 21st, 2021 and there have been no changes since October 24th, 2022."
Are there other examples in the medical literature of patients being transitioned from one immunosuppressant medication to another?
"At the moment, there are 264 on-going clinical trials investigating Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap. 36 of these studies are in Phase 3 and most originate from Philadelphia, Pennsylvania. However, research is being conducted at 1795 different locations for Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap."
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