Study Comparing in Livertransplantation Recipients With Tacrolimus Alone Versus Tacrolimus&Sirolimus

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study we compare long term renal function in liver transplantation recipients treated with standard dose extended-release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus. The hypothesis is that the patients treated with the combination have better long term renal function than the patients treated with standard dose tacrolimus alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Liver Research
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Primary liver transplantation or retransplantation within 14 days after first transplantation

• Use of Advagraf at least 2 weeks prior to randomization

• Patent hepatic artery

• Closed abdominal wound

• Stable graft function

• Positive informed consent at time of randomization

• Age 18-70 years

Exclusion Criteria:

• Treatment with investigational drugs within 3 months before start of therapy

• Multi organ transplantation

• cGFR < 30 ml/min

• Proteinuria > 800 mg/24 h

• Hyperlipidemia refractory to optimal medical management (Cholesterol > 9 mmol/l and/or triglycerides > 8.5 mmol/l). Patients with controlled hyperlipidemia are acceptable at the time of randomization.

• Known hypersensitivity to sirolimus or its derivatives

• Thrombocytes < 50 x 109 /L

• Leukocytes < 2.5 x 109 /L

• Haemoglobin < 6 mmol/L

• Biopsy proven rejection 2 weeks prior to randomization

• HIV positivity

• Signs of recurrent or de novo cancer

• Patients with non-HCC malignancies within the past 5 years (excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin)

• Evidence of significant local or systemic infection

• Pregnancy or breast feeding

• Women of child-bearing potential not willing to take oral contraception

• Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study