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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Medical Center Goettingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Armin Goralczyk, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT00890253
First received: April 28, 2009
Last updated: September 14, 2011
Last verified: January 2010
  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
Drug: Prednisolone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
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

Locations
Germany
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
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 by University Medical Center Goettingen

Additional 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
Study First Received: April 28, 2009
Last Updated: September 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Sirolimus
Mycophenolate mofetil
Everolimus
Basiliximab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014