NCT00890253

Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Armin Goralczyk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.

Conditions

• Liver Transplantation
• Chronic Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Basiliximab (Simulect)	20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT
DRUG	Myfortic	1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
DRUG	everolimus	1 mg q12 everolimus (Certican) po starting on 10th post-operative day
DRUG	Prednisolone	Prednisolone 1mg per kg body weight starting within 24 hours after transplantation. Then q24 but with reduction by 5 mg every 48 hours until maintenance dose of 7.5 mg

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-01-01
• Completion: 2013-01-01
• First posted: 2009-04-29
• Last updated: 2011-09-15

Locations

1 site across 1 country: Germany