NCT01625377: SIMCER

A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients

Completed Phase 3 Results posted Last updated 25 March 2016

What this trial tests

Phase 3 trial testing tacrolimus in Liver Transplantation in 188 participants. Completed in 1 March 2015.

Timeline

1 December 2012

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	188
Start date	1 December 2012
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	14 locations across France

Drugs / interventions tested

• tacrolimus (TACROLIMUS) — full drug profile →
• everolimus (everolimus) — full drug profile →
• Basiliximab (BASILIXIMAB) — full drug profile →
• Mycophenolic Acid (MYCOPHENOLIC ACID) — full drug profile →
• Corticosteroids

Conditions studied

• Liver Transplantation — all drugs for Liver Transplantation →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline (Randomization) in Renal Function
  Time frame: Baseline, Week 24
  Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula. GFR in mL/min/1.73m\^2 for men of non-black ethnicity: 186 \* \[C/88\]\^-1.154 \* \[A\]\^-0.023\*G\*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 whe

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of mTOR Inhibitors in Liver Transplantation: Reviewing the Evidence.
   Klintmalm GB, Nashan B. · · 2014 · cited 51× · PMID 24719752 · DOI 10.1155/2014/845438
2. The role of everolimus in liver transplantation.
   Ganschow R, Pollok JM, Jankofsky M, Junge G. · · 2014 · cited 27× · PMID 25214801 · DOI 10.2147/ceg.s41780
3. Five-year outcomes in liver transplant patients receiving everolimus with or without a calcineurin inhibitor: Results from the CERTITUDE study.
   Saliba F, Duvoux C, Dharancy S, Dumortier J, et al · · 2022 · cited 8× · PMID 35962772 · DOI 10.1111/liv.15396