New drug combo after liver transplant may help kidneys recover faster

NCT ID NCT04104438

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different combinations of immunosuppressive drugs in 71 adults who had a liver transplant and were on dialysis. The goal was to see if newer drug combinations could help the kidneys recover better and allow patients to stop dialysis sooner. The study compared three groups, each receiving a different mix of medications to prevent organ rejection while protecting kidney function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

71 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 78 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. A signed informed consent prior to patient participation in the study and before any assessment is performed. 2. Patients who are able to take oral medication. 3. 18 years old 4. Undergoing first OLT 5. Dialysis for 45 days or less at time of transplant 6. Able and willing to conform to requirements of the study 7. Able and willing to provide informed consent Exclusion Criteria: <!-- --> 1. \< 18 years old 2. Autoimmune liver disease, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis 3. Dialysis greater than 45 days 4. Receiving ATG, IVIG therapy, or sirolimus/everolimus around time of transplant or sirolimus/everolimus after transplant 5. Unable to take oral medications 6. Participating in another clinical research study involving the evaluation of another investigational drug or device 7. Documented allergy to basiliximab, TAC, MMF or any macrolide antibiotic. 8. Presence of thrombosis of any major hepatic arteries 9. Complex/high risk arterial reconstruction at any time (graft vessel patency by Doppler ultrasound confirmed and documented). 10. 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. 11. Patients who have severe hypercholesterolemia (\>215 mg/dL; \>5.5 mmol/L) or hypertriglyceridemia (\>265 mg/dL; \>3.0 mmol/L) at Baseline. 12. Patients who have severe thrombocytopenia or neutropenia (platelet count \>20 and MLCs\>1000) 13. 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 14. Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients. 15. Patients with clinically significant systemic infection 16. 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.

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As listed by the trial registrant

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Contacts and locations

Locations

  • UCLA Medical Center

    Los Angeles, California, 90095, United States