Phase 4
N=71
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
Asses Immunosuppression Modulation on Renal Recovery Post LT
Bottom Line
View on ClinicalTrials.gov: NCT04104438 ↗Enrolled (actual)
71
Serious AEs
31.0%
Results posted
Dec 2025
Primary outcome: Primary: Participants Who Have Recovered Renal Function — 28; 20; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Basiliximab 20 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fady M Kaldas, M.D., F.A.C.S.
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Have Recovered Renal Function |
28; 20; 11 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04104438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.