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

NCT00890253 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2011-09-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Armin Goralczyk

    lead OTHER

Principal Investigators

  • Aiman Obed, PD Dr. · University Medical Center Goettingen

  • Armin D Goralczyk, Dr. · University Medical Center Goettingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-01-31
Completion
2013-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890253 on ClinicalTrials.gov