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

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ClinicalTrials.gov Identifier: NCT00890253
Recruitment Status : Unknown
Verified January 2010 by Armin Goralczyk, University Medical Center Goettingen.
Recruitment status was:  Recruiting
First Posted : April 29, 2009
Last Update Posted : September 15, 2011
Information provided by (Responsible Party):
Armin Goralczyk, University Medical Center Goettingen

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
Liver Transplantation Chronic Renal Insufficiency Drug: Basiliximab (Simulect) Drug: Myfortic Drug: everolimus Drug: Prednisolone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
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 : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources

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 Name: Basiliximab: Simulect
Drug: Myfortic
1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
Other Name: Enteric-coated mycophenolate sodium: EC-MPS, Myfortic
Drug: everolimus
1 mg q12 everolimus (Certican) po starting on 10th post-operative day
Other Name: 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 Name: Prednisone

Primary Outcome Measures :
  1. Steroid resistant rejection [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Steroid resistant rejection [ Time Frame: 1 year ]
  2. Liver function [ Time Frame: 1 year ]
  3. Calculated glomerular filtration rate [ Time Frame: 1 year ]
  4. Patient survival [ Time Frame: 1 year ]
  5. Number of days on renal replacement therapy [ Time Frame: 1 year ]
  6. Graft survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890253

Contact: Aiman Obed, Prof. Dr. +49 551 3912296 aobed@chirurgie-goettingen.de
Contact: Armin D Goralczyk, MD +49 551 3914638 agoralczyk@med.uni-goettingen.de

University Medical Center Goettingen Recruiting
Goettingen, Germany, 37099
Contact: Armin D Goralczyk, Dr.    +49 551 398490    agoralczyk@med.uni-goettingen.de   
Contact: Aiman Obed, PD Dr.    +49 551 39 12296    aobed@chirurgie-goettingen.de   
Principal Investigator: Aiman Obed, Prof. Dr.         
Sub-Investigator: Armin D Goralczyk, MD         
Sponsors and Collaborators
Armin Goralczyk
Study Director: Aiman Obed, PD Dr. University Medical Center Goettingen
Principal Investigator: Armin D Goralczyk, Dr. University Medical Center Goettingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armin Goralczyk, Dr., University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT00890253     History of Changes
Other Study ID Numbers: CILT08
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: January 2010

Keywords provided by Armin Goralczyk, University Medical Center Goettingen:
Renal impairment
Liver transplantation
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Methylprednisolone Hemisuccinate
Antibodies, Monoclonal
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Calcineurin Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents