Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
Source: ClinicalTrials.gov NCT01598987 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Estimated Glomerular Filtration Rate - Month 12 |
6.2 | — |
| SECONDARY Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints |
1.9; 1.9; 1.9; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate - Month 24 |
4.5 | — |
| SECONDARY Growth Development - Height at Baseline and Month 12 |
0.0; 26.7; 16.7; 14.3; 25.0; 0.0 | — |
| SECONDARY Growth Development - Weight at Baseline and Month 12 |
0.0; 20.0; 42.9; 72.7; 16.7; 0.0 | — |
| SECONDARY Growth Development - Weight at Baseline and Month 24 |
0.0; 40.0; 100.0; 12.5; 0.0; 22.7 | — |
| SECONDARY Growth Development - Height at Baseline and Month 24 |
0.0; 12.5; 33.3; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Key Inclusion Criteria
Signed informed consent from both parents or legal guardian(s) prior to patient participation in the study.
Paediatric liver transplant recipients aged greater than or equal to 1 month and younger than 18 years of age.
Paediatric recipients at the earliest 1 month and latest 6 month after liver transplantation.
Key Exclusion Criteria
Patients with hepato-biliary malignancies and/or patients transplanted due to fulminant hepatitis /acute liver failure.
Presence of thrombosis of any major hepatic arteries, major/reconstructed hepatic veins, portal vein or inferior vena cava at any time prior to the start of study drug.
Patients with serum creatinine value >2 times age-related ULN at Baseline or who received renal replacement therapy within one week prior to the start of study drug and patients with a confirmed spot urine protein/creatinine ratio indicating a urinary protein excretion >500 mg/m2/24 hrs, at Baseline.
Patients with clinically significant systemic infection and/or in a critical care setting requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents.
Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
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.
Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they agree for abstinence from sexual activity.
Data sourced from ClinicalTrials.gov (NCT01598987). 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. Informational only — not medical advice.