New drug combo after liver transplant may help kidneys recover faster
NCT ID NCT04104438
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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71 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Sep 2024
- Lead sponsor
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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
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18 to 78 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UCLA Medical Center
Los Angeles, California, 90095, United States