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Immunosuppression with Basiliximab for Kidney Function Post-Liver Transplant
Study Summary
This trial will compare new immunosuppressive medications to standard ones to see how well they work and if they are safe.
Timeline
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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Who is running the clinical trial?
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- You have autoimmune liver disease, primary sclerosing cholangitis, or primary biliary cirrhosis.You have a serious infection that affects your whole body.You have a known allergy to basiliximab, TAC, MMF, or any macrolide antibiotic.You have recently received certain medications like ATG, IVIG, or sirolimus/everolimus before or after a transplant.
- Group 1: Basliximab, Delayed TAC with Everolimus
- Group 2: Control: standard TAC with steroids and MMF
- Group 3: Basiliximab with Delayed TAC
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is this trial open to participants of a certain age, and if so, what is the upper limit?
"This trial mandates that participants are in the 18 to 78 year age bracket. For those too young or old for this clinical study, there is an alternate selection of 16 trials available for minors and 97 studies designed with seniors in mind."
How many participants has this research program enrolled thus far?
"Affirmative. According to clinicaltrials.gov, the trial opened on January 15th 2021 and was last updated in July 6th 2022. The experiment seeks 90 individuals at one medical facility for enrollment."
What medical afflictions are Basliximab, Delayed TAC with Everolimus utilized to address?
"Basliximab, Delayed TAC with Everolimus is highly utilized to treat liver and kidney transplant rejections. Additionally, this drug has proven successful in managing waldenstrom macroglobulinemia."
Are new participants being added to this research project presently?
"Indeed, those interested in participating can find information about the study on clinicaltrials.gov. It was first made available to patients and carers on January 15th 2021 and is still being actively recruited for with the most recent update published July 6th 2022."
Is this a pioneering exploration into the field of research?
"Since 2007, Basliximab, Delayed TAC with Everolimus has been subject to scientific inquiry. CellTrans Inc. sponsored the initial trial in that year which featured 21 patients; this was followed by a successful Phase 3 drug approval process. Today, 106 research activities are ongoing for Basilximab across 1226 cities and 45 countries globally."
Can you elaborate on the risks associated with Basliximab, Delayed TAC and Everolimus?
"Our assessment at Power rates the safety of Basliximab and Delayed TAC with Everolimus as a 3, due to it being in Phase 4 trials - signifying that this treatment is formally accepted for use."
How may I submit my application to participate in this research?
"To qualify for this medical study, applicants must demonstrate fluorescence recovery after photobleaching and be between 18-78 years old. The total number of recruits needed is 90 individuals."
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