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Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation (CILT)
This study is not yet open for participant recruitment.
Verified by University Medical Center Goettingen, April 2009
First Received: April 28, 2009   No Changes Posted
Sponsored by: University Medical Center Goettingen
Information provided by: University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT00890253
  Purpose

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 Intervention Phase
Liver Transplantation
Chronic Renal Insufficiency
Drug: Basiliximab (Simulect)
Drug: Myfortic
Drug: everolimus (Certican)
Drug: Prednisolone
Phase II

MedlinePlus related topics: Liver Transplantation
Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Mycophenolic acid Medrol veriderm Methylprednisolone Everolimus Basiliximab Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free de-Novo Immunosuppression After Liver Transplantation

Further study details as provided by University Medical Center Goettingen:

Primary Outcome Measures:
  • Steroid resistant rejection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Steroid resistant rejection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Liver function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Calculated glomerular filtration rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of days on renal replacement therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Graft survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 29
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CNI-free Immunosuppression: Experimental
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
Drug: Myfortic
1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
Drug: everolimus (Certican)
1 mg q12 everolimus (Certican) po starting on 10th post-operative day
Drug: Prednisolone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890253

Locations
Germany
University Medical Center Goettingen
Goettingen, Germany, 37099
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
Study Director: Aiman Obed, PD Dr. University Medical Center Goettingen
Principal Investigator: Armin D Goralczyk, Dr. University Medical Center Goettingen
  More Information

No publications provided

Responsible Party: University Medical Center Goettingen ( PD Dr. Aiman Obed )
Study ID Numbers: CILT08
Study First Received: April 28, 2009
Last Updated: April 28, 2009
ClinicalTrials.gov Identifier: NCT00890253     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Renal Insufficiency
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Mycophenolic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Prednisolone acetate
Hormones
Antibodies, Monoclonal
Anti-Bacterial Agents
Urologic Diseases
Mycophenolate mofetil
Kidney Diseases
Methylprednisolone Hemisuccinate
Immunoglobulins
Everolimus
Antineoplastic Agents, Hormonal
Methylprednisolone acetate
Glucocorticoids
Immunosuppressive Agents
Basiliximab
Antibodies
Renal Insufficiency, Chronic
Prednisolone

Additional relevant MeSH terms:
Everolimus
Anti-Inflammatory Agents
Renal Insufficiency
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Mycophenolic Acid
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Antibodies, Monoclonal
Basiliximab
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Prednisolone
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009