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Monoclonal Antibodies
Immunosuppression with Basiliximab for Kidney Function Post-Liver Transplant
Phase 4
Waitlist Available
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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Renal Function
Other study objectives
cumulative allograft rejection
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Basliximab, Delayed TAC with Everolimus
- Group 2: Control: standard TAC with steroids and MMF
- Group 3: Basiliximab with Delayed TAC
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- 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.
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