Asses Immunosuppression Modulation on Renal Recovery Post LTPhase 4NCT04104438

Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant

A Phase 4 study testing Basiliximab 20 MG in people with Asses Immunosuppression Modulation on Renal Recovery Post LT, run by Fady M Kaldas, M.D., F.A.C.S. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Asses Immunosuppression Modulation on Renal Recovery Post LT
What is being tested?: Basiliximab 20 MG
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2021to 30 Sep 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
A signed informed consent prior to patient participation in the study and before any assessment is performed.
Patients who are able to take oral medication.
18 years old
Undergoing first OLT
Dialysis for 45 days or less at time of transplant
Able and willing to conform to requirements of the study
Able and willing to provide informed consent

Who cannot join

< 18 years old
Autoimmune liver disease, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
Dialysis greater than 45 days
Receiving ATG, IVIG therapy, or sirolimus/everolimus around time of transplant or sirolimus/everolimus after transplant
Unable to take oral medications

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Participating in another clinical research study involving the evaluation of another investigational drug or device
Documented allergy to basiliximab, TAC, MMF or any macrolide antibiotic.
Presence of thrombosis of any major hepatic arteries
Complex/high risk arterial reconstruction at any time (graft vessel patency by Doppler ultrasound confirmed and documented).
Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an ABO incompatible transplant.
Patients who have severe hypercholesterolemia (>215 mg/dL; >5.5 mmol/L) or hypertriglyceridemia (>265 mg/dL; >3.0 mmol/L) at Baseline.
Patients who have severe thrombocytopenia or neutropenia (platelet count >20 and MLCs>1000)
Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drugs
Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
Patients with clinically significant systemic infection
Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive βHCG laboratory test (>9 mIU/mL) at Baseline.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Medical Center
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Study in Adults on Pre LT Dialysis With Basiliximab, Delayed Tacrolimus (TAC), Mycophenolate (MMF), Steroids (Grp 1) vs. Basiliximab, Delayed TAC, MMF, Steroids, With Everolimus 30d Post LT(Grp 2), vs. TAC, MMF, Steroids (Grp 3).

This is a study to help understand how well new combinations of immunosuppressive medications (medications that weaken your immune system to prevent your body from rejecting the transplanted liver) work compared to standard immunosuppressive medications after your liver transplant. Also the study will assess how safe the new combination of immunosuppressive medicines are and if there are any changes in how your kidneys work after taking these medicines.

Read the detailed description

A single center, open label, randomized, prospective, pilot study of induction and maintenance immunosuppression in adult subjects >18 years undergoing orthotopic liver transplantation (OLT) with Basiliximab, delayed dose tacrolimus plus mycophenolate mofetil and standard of care (SOC) corticosteroids (Group 1) versus basiliximab, delayed dose tacrolimus plus mycophenolate mofetil, SOC corticosteroids, with addition of delayed maintenance Everolimus at one month post OLT with subsequent mycophenolate mofetil minimization (Group 2) versus standard dose tacrolimus plus mycophenolate mofetil plus SOC corticosteroids (Group 3; control) with concomitant renal dysfunction prior to OLT.

Conditions: Asses Immunosuppression Modulation on Renal Recovery Post LT
Being tested: Basiliximab 20 MG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Basiliximab 20 MGDrug
Also called Everolimus
Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30

Study groups in NCT04104438
Study group	Role	What they receive
basiliximab with Delayed TAC	Active comparator	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 Receives: Drug: Basiliximab 20 MG
basiliximab, Delayed TAC with Everolimus	Active comparator	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. Receives: Drug: Basiliximab 20 MG
Control: standard TAC with steroids and MMF	No 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants Who Have Recovered Renal Function
Assessment of dialysis independence (patients no longer requiring dialysis post LT)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202130 Sep 2024

First posted26 Sep 2019
Study start15 Jan 2021
Primary completion30 Sep 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Asses Immunosuppression Modulation on Renal Recovery Post LTStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: To assess the efficacy and safety of basiliximab, delayed dose tacrolimus plus mycophenolate mofetil, and SOC corticosteroids versus basiliximab, delayed dose tacrolimus plus mycophenolate mofetil, and SOC corticosteroids and addition of delayed everolimus/mycophenolate minimization at one month post OLT compared to standard triple immunosuppression (tacrolimus, mycophenolate mofetil and corticosteroids) for prevention of acute organ rejection in liver transplant recipients with a high risk of developing renal dysfunction following OLT or with concomitant renal dysfunction prior to OLT.
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04104438
Sponsor's protocol ID: Novartis18-000215
Status last verified: Dec 2025
First submitted: 30 May 2019
Last updated: 16 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study in Adults on Pre LT Dialysis With Basiliximab, Delayed Tacrolimus (TAC), Mycophenolate (MMF), Steroids (Grp 1) vs. Basiliximab, Delayed TAC, MMF, Steroids, With Everolimus 30d Post LT(Grp 2), vs. TAC, MMF, Steroids (Grp 3).
ClinicalTrials.gov ID: NCT04104438
Acronym / sponsor ID: Novartis18-000215
Conditions: Asses Immunosuppression Modulation on Renal Recovery Post LT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Fady M Kaldas, M.D., F.A.C.S.University, hospital or other
Study start: 15 Jan 2021 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 26 Sep 2019 (actual)
Results: Posted 16 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: To assess the efficacy and safety of basiliximab, delayed dose tacrolimus plus mycophenolate mofetil, and SOC corticosteroids versus basiliximab, delayed dose tacrolimus plus mycophenolate mofetil, and SOC corticosteroids and addition of delayed everolimus/mycophenolate minimization at one month post OLT compared to standard triple immunosuppression (tacrolimus, mycophenolate mofetil and corticosteroids) for prevention of acute organ rejection in liver transplant recipients with a high risk of developing renal dysfunction following OLT or with concomitant renal dysfunction prior to OLT.

Arm	Type	Receives
basiliximab with Delayed TAC	Active comparator	Drug: Basiliximab 20 MGbasiliximab * 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
basiliximab, Delayed TAC with Everolimus	Active comparator	Drug: Basiliximab 20 MGbasiliximab 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.
Control: standard TAC with steroids and MMF	No 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

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

Key exclusion criteria (17 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Basiliximab 20 MGAlso: EverolimusBasiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30	Drug	basiliximab with Delayed TAC, basiliximab, Delayed TAC with Everolimus

Primary outcome

Participants Who Have Recovered Renal Function
Time frame: 6 months
Assessment of dialysis independence (patients no longer requiring dialysis post LT)

Results and safety

Results posted to the registry on 16 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Basiliximab With Delayed TAC	30	28
Basliximab, Delayed TAC With Everolimus	28	20
Control: Standard TAC With Steroids and MMF	13	11

Primary outcome: Participants Who Have Recovered Renal Function

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Basiliximab With Delayed TAC n = 28	Basliximab, Delayed TAC With Everolimus n = 20	Control: Standard TAC With Steroids and MMF n = 11
Value	28	20	11

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Basiliximab With Delayed TAC	14 of 30 (46.7%)	14 of 30 (46.7%)	2 of 30
Basliximab, Delayed TAC With Everolimus	7 of 28 (25%)	18 of 28 (64.3%)	1 of 28
Control: Standard TAC With Steroids and MMF	1 of 13 (7.7%)	8 of 13 (61.5%)	2 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fady M Kaldas, MD principal investigator

UCLA Dept Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Basiliximab 20 MG in people with Asses Immunosuppression Modulation on Renal Recovery Post LT, run by Fady M Kaldas, M.D., F.A.C.S. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Who Have Recovered Renal Function (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.