Study to evaluate the renal function of adult liver transplant recipients treated with two everolimus-based immunosuppressive regimens (tacrolimus withdrawal vs. minimization) until 12 months post-transplant, with a 6-months follow-up.

Multicenter, prospective, open-label, controlled, randomized, parallel groups study to evaluate the renal function of adult liver transplant recipients treated with two everolimus-based immunosuppressive regimens (tacrolimus withdrawal vs. minimization) until 12 months post-transplant, with a 6-months follow-up. REFLECT study. - REFLECT study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004325-91-IT

Enrollment

Unknown

Registered

2013-11-29

Start date

2014-01-25

Completion date

Unknown

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver transplant MedDRA version: 14.1 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 100000004865

Interventions

Trade Name: Certican Product Name: Certican 0,25 mg Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Current Sponsor code: RAD001 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria at Baseline (Visit 1) • Male and female liver transplant recipients who are = 18 years of age, treated with a tacrolimus-based immunosuppressive regimen, who have received an induction therapy or i.v. steroids as per local clinical practice. • Recipients of a full-size or technically modified liver allograft will be eligible at 4 weeks (± 7 days) after liver transplantation. • Allograft is functioning at an acceptable level by the time of Baseline as defined by the AST, ALT, total bilirubin levels = 3 times ULN and INR =65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: Exclusion criteria at Baseline (Visit 1) • 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 AB0 incompatible transplant. • Patients who experienced more than one episode of treated biopsy proven acute rejection (BANFF = 3 or RAI = 7) or one steroid-resistant acute rejection. • Patients who require renal replacement therapy. • Patients with a confirmed spot urine protein/creatinine ratio that indicates =1.0 g/24 hrs of proteinuria. • History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC. Exclusion criteria at Randomization (Visit 5) • Patients who experienced more than two episodes of treated biopsy proven acute rejection (BANFF = 3 or RAI = 7) since transplantation or one steroid-resistant acute rejection during the run-in period. • Patients with a confirmed spot urine protein/creatinine ratio that indicates = 3.0 g/24 hrs of proteinuria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare at Month 12 post-transplantation the renal function, measured by estimated GFR (MDRD-4), between tacrolimus withdrawal regimen and early tacrolimus minimization regimen, both facilitated by everolimus introduction 4 weeks after liver transplantation.;Secondary Objective: To evaluate between groups at Months 12 post-transplantation: • composite efficacy failure rate of treated biopsy proven acute rejection (tBPAR), graft loss (GL) or death (D); • incidence of each component of the composite efficacy endpoint and loss to follow-up; • incidence of a composite of death (D) or graft loss (GL); • t-BPAR by: (1) incidence, (2) time to event, (3) severity, (4) diagnosis leading to transplantation; • any acute rejection by: (1) incidence, (2) time to event, (3) severity; • evolution of post-randomization renal function over time assessed by the change in estimated GFR (MDRD-4) to Month 12; • incidence of patients experiencing a decline/improvement in eGFR of <10, 10<15, 15<20, 20<25, and =25 mL/min/1.73m2 from Baseline to randomization and from randomization to Month 12; • serum creatinine at various time points; • evolution of renal function by chronic kidney disease (CKD) strata; For other secondary objectives please refer to the protocol. ;Primary end point(s): Renal function by the abbreviated MDRD equation;Timepoint(s) of evaluation of this end point: 12 months post-trasplantation	—

Measure

Time frame

Main Objective: To compare at Month 12 post-transplantation the renal function, measured by estimated GFR (MDRD-4), between tacrolimus withdrawal regimen and early tacrolimus minimization regimen, both facilitated by everolimus introduction 4 weeks after liver transplantation.;Secondary Objective: To evaluate between groups at Months 12 post-transplantation: • composite efficacy failure rate of treated biopsy proven acute rejection (tBPAR), graft loss (GL) or death (D); • incidence of each component of the composite efficacy endpoint and loss to follow-up; • incidence of a composite of death (D) or graft loss (GL); • t-BPAR by: (1) incidence, (2) time to event, (3) severity, (4) diagnosis leading to transplantation; • any acute rejection by: (1) incidence, (2) time to event, (3) severity; • evolution of post-randomization renal function over time assessed by the change in estimated GFR (MDRD-4) to Month 12; • incidence of patients experiencing a decline/improvement in eGFR of <10, 10<15, 15<20, 20<25, and =25 mL/min/1.73m2 from Baseline to randomization and from randomization to Month 12; • serum creatinine at various time points; • evolution of renal function by chronic kidney disease (CKD) strata; For other secondary objectives please refer to the protocol. ;Primary end point(s): Renal function by the abbreviated MDRD equation;Timepoint(s) of evaluation of this end point: 12 months post-trasplantation

—

Secondary

Measure	Time frame
Secondary end point(s): • Treated Biopsy-Proven Acute Rejection • Death • Graft Loss • Recurrence rate of hepatocellular carcinoma • Progression of fibrosis in HCV positive patients • Incidence of viral infections • Incidence of new-onset diabetes post-transplantation;Timepoint(s) of evaluation of this end point: 12 months post-trasplantation and 18 months post-trasplantation	—

Countries

Italy

Contacts

Public ContactDrug Regulatory Affairs

NOVARTIS FARMA S.p.a

info.studiclinici@novartis.com+390296541

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026