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

Sponsor
Armin Goralczyk (Other)
Overall Status
Unknown status
CT.gov ID
NCT00890253
Collaborator
(none)
29
Enrollment
1
Location
1
Arm
36
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation
Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Jan 1, 2012
Anticipated Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: CNI-free Immunosuppression

Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.

Drug: Basiliximab (Simulect)
20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT
Other Names:
  • Basiliximab: Simulect

    • Drug: Myfortic
    1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
    Other Names:
  • Enteric-coated mycophenolate sodium: EC-MPS, Myfortic

    • Drug: everolimus
    1 mg q12 everolimus (Certican) po starting on 10th post-operative day
    Other Names:
  • Certican

    • 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
    Other Names:
  • Prednisone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Steroid resistant rejection [30 days]

    Secondary Outcome Measures

    1. Steroid resistant rejection [1 year]

    2. Liver function [1 year]

    3. Calculated glomerular filtration rate [1 year]

    4. Patient survival [1 year]

    5. Number of days on renal replacement therapy [1 year]

    6. Graft survival [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients undergoing primary liver transplantation.

    2. Patients older than 18 years.

    3. Patients with a hepatorenal syndrome.

    4. Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.

    5. eGFR < 50 ml/min at the time point of transplantation.

    6. Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation.

    Exclusion Criteria:

    1. Patients with pre-transplant renal replacement therapy > 14 days.

    2. Patients with a reason for renal impairment other than a hepatorenal syndrome.

    3. Patients with a known hypersensitivity to mTOR-inhibitors.

    4. Patients with a known hypersensitivity to mycophenolate acid.

    5. Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.

    6. Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition.

    7. Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.

    8. Severe systemic infections and wound-healing disturbances.

    9. Multiple organ graft recipients.

    10. Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.

    11. Pregnant women will not be included in the study.

    12. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.

    13. Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Goettingen Goettingen Germany 37099

    Sponsors and Collaborators

    • Armin Goralczyk

    Investigators

    • Study Director: Aiman Obed, PD Dr., University Medical Center Goettingen
    • Principal Investigator: Armin D Goralczyk, Dr., University Medical Center Goettingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Armin Goralczyk, Dr., University Medical Center Goettingen
    ClinicalTrials.gov Identifier:
    NCT00890253
    Other Study ID Numbers:
    • CILT08
    First Posted:
    Apr 29, 2009
    Last Update Posted:
    Sep 15, 2011
    Last Verified:
    Jan 1, 2010
    Keywords provided by Armin Goralczyk, Dr., University Medical Center Goettingen
    Renal impairment
    Liver transplantation
    Chronic Renal Insufficiency
    Additional relevant MeSH terms:
    Renal Insufficiency
    Renal Insufficiency, Chronic
    Mycophenolic Acid
    Prednisone
    Prednisolone
    Everolimus
    Basiliximab

    Study Results

    No Results Posted as of Sep 15, 2011