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Monoclonal Antibodies

Immunosuppression with Basiliximab for Kidney Function Post-Liver Transplant

Q: 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.

Q: 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.

Q: What medical afflictions are Basliximab, Delayed TAC with Everolimus utilized to address?

Basliximab, Delayed TAC with Everolimus is highly utilized to treat liver and <a href="https://www.withpower.com/clinical-trials/kidney-transplant">kidney transplant</a> rejections. Additionally, this drug has proven successful in managing waldenstrom macroglobulinemia.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Phase 4

Recruiting

Led By Fady M Kaldas, MD

Research Sponsored by Fady M Kaldas, M.D., F.A.C.S.

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 6 months

Awards & highlights

Study Summary

This trial will compare new immunosuppressive medications to standard ones to see how well they work and if they are safe.

Who is the study for?

This trial is for adults who can take oral meds and are having their first liver transplant. They should have been on dialysis for no more than 45 days. It's not for those under 18, with certain liver diseases, high cholesterol or triglycerides, severe blood disorders, other complex medical conditions, or who've had multiple transplants.Check my eligibility

What is being tested?

The study tests a new combo of immunosuppressive drugs (which prevent the body from rejecting a new liver) against standard ones to see how they affect kidney function post-liver transplant.See study design

What are the potential side effects?

Possible side effects may include weakened immune system leading to infections, allergic reactions to the medication Basiliximab or any macrolide antibiotic included in the treatment regimen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Renal Function

Other outcome measures

cumulative allograft rejection

Trial Design

3Treatment groups

Active Control

Group I: Basliximab, Delayed TAC with EverolimusActive Control1 Intervention

Basiliximab Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr < 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated Corticosteroids (SOC): Per UCLA protocol Everolimus (delayed) o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.

Group II: Control: standard TAC with steroids and MMFActive Control1 Intervention

Tacrolimus (without basiliximab induction) Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL Six months to one year: maintain whole blood trough concentration of 5-10ng/mL Mycophenolate mofetil o 1000 mg po bid Corticosteroids (SOC): Per UCLA protocol

Group III: Basiliximab with Delayed TACActive Control1 Intervention

Basiliximab Dose #1: 20mg IV within 2 hours of transplant Dose #2: 20mg IV Post-operative day #4 Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr < 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL Mycophenolate mofetil o 1000 mg po bid Corticosteroids (SOC): Per UCLA protocol Post-operative taper: Post-op day 1- methylprednisolone 50mg IVP Q6H Post-op day 2- methylprednisolone 40mg IVP Q6H Post-op day 3- methylprednisolone 30mg IVP Q6H Post-op day 4- methylprednisolone 20mg IVP Q6H Post-op day 5- methylprednisolone 20mg IVP Q12H Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fady M Kaldas, M.D., F.A.C.S.Lead Sponsor

Fady M Kaldas, MDPrincipal InvestigatorUCLA Dept Surgery

1 Previous Clinical Trials

59 Total Patients Enrolled

Media Library

Basiliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04104438 — Phase 4

Assessing Renal Recovery After Liver Transplantation Research Study Groups: Basliximab, Delayed TAC with Everolimus, Control: standard TAC with steroids and MMF, Basiliximab with Delayed TAC

Assessing Renal Recovery After Liver Transplantation Clinical Trial 2023: Basiliximab Highlights & Side Effects. Trial Name: NCT04104438 — Phase 4

Basiliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04104438 — Phase 4

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant

Fady M Kaldas, M.D., F.A.C.S. 2021. "Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04104438.

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