Phase 3 N=188 Randomized Treatment

A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients

Liver Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT01625377 ↗

Enrolled (actual)

188

Serious AEs

38.0%

Results posted

Apr 2016

Primary outcome: Primary: Change From Baseline (Randomization) in Renal Function — -13.29; 1.05 mL/min/1.73m^2 — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: tacrolimus (Drug); everolimus (Drug); Basiliximab (Drug); Mycophenolic Acid (Drug); Corticosteroids (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline (Randomization) in Renal Function	-13.29; 1.05	<0.0001 sig
SECONDARY Number of Patients With Treatment Failures	91; 88; 2; 2; 89; 81	—
SECONDARY Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)	2; 2; 0; 0; 2; 8	—
SECONDARY Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification	1; 1; 1; 1; 0; 0	—
SECONDARY Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3	0; 0; 0; 1; 2; 8	—
SECONDARY Number of Patients With Death or Graft Loss	1; 0; 1; 1	—
SECONDARY Change From Baseline (Randomization) in Serum Creatinine	7.2; -1.3	—
SECONDARY Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio	-2.3; 21.9	—
SECONDARY Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula	-9.0; 0.7	—
SECONDARY Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula	-11.8; 0.1	—
SECONDARY Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula	-6.9; 2.4	—
SECONDARY Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System	24; 41; 34; 29; 28; 4	—
SECONDARY Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation	85; 81; 28; 42; 1; 2	—

Summary

The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS. The renal function was estimated by glomerular filtration rate.

Eligibility Criteria

Key Inclusion Criteria

Man or woman aged 18 years or greater, recipient of a primary liver transplant from a deceased donor with whole or split liver

Key Exclusion Criteria

Patient recipient of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant
Recipient of a liver from a living donor or cadaveric non heart beating donor
ABO incompatible transplant graft
Transplantation following autoimmune liver hepatitis, primitive sclerosing cholangitis or primitive biliary cirrhosis
Estimated glomerular filtration rate ≤ 30ml/min at selection
History of malignancy within the 5 past years, other than non-metastatic basal or squamous cell carcinoma and hepatocellular carcinoma
Alpha-foeto-protein > 1000 ng/ml (only in case of hepatocellular carcinoma)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01625377). 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.