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

Primary Purpose

Liver Transplantation, Chronic Renal Insufficiency

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Basiliximab (Simulect)

Myfortic

everolimus

Prednisolone

About this trial

This is an interventional treatment trial for Liver Transplantation focused on measuring Renal impairment, Liver transplantation, Chronic Renal Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing primary liver transplantation.
Patients older than 18 years.
Patients with a hepatorenal syndrome.
Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
eGFR < 50 ml/min at the time point of transplantation.
Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation.

Exclusion Criteria:

Patients with pre-transplant renal replacement therapy > 14 days.
Patients with a reason for renal impairment other than a hepatorenal syndrome.
Patients with a known hypersensitivity to mTOR-inhibitors.
Patients with a known hypersensitivity to mycophenolate acid.
Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition.
Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
Severe systemic infections and wound-healing disturbances.
Multiple organ graft recipients.
Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.
Pregnant women will not be included in the study.
Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).

Sites / Locations

University Medical Center GoettingenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CNI-free Immunosuppression

Arm Description

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

Outcomes

Primary Outcome Measures

Steroid resistant rejection

Secondary Outcome Measures

Steroid resistant rejection

Liver function

Calculated glomerular filtration rate

Patient survival

Number of days on renal replacement therapy

Graft survival

Full Information

NCT ID

NCT00890253

First Posted

April 28, 2009

Last Updated

September 14, 2011

Sponsor

Armin Goralczyk

1. Study Identification

Unique Protocol Identification Number

NCT00890253

Brief Title

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

Acronym

CILT

Official Title

A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Armin Goralczyk

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Transplantation, Chronic Renal Insufficiency

Keywords

Renal impairment, Liver transplantation, Chronic Renal Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CNI-free Immunosuppression

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Basiliximab (Simulect)

Other Intervention Name(s)

Basiliximab: Simulect

Intervention Description

20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT

Intervention Type

Drug

Intervention Name(s)

Myfortic

Other Intervention Name(s)

Enteric-coated mycophenolate sodium: EC-MPS, Myfortic

Intervention Description

1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT

Intervention Type

Drug

Intervention Name(s)

everolimus

Other Intervention Name(s)

Certican

Intervention Description

1 mg q12 everolimus (Certican) po starting on 10th post-operative day

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Other Intervention Name(s)

Prednisone

Intervention Description

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

Primary Outcome Measure Information:

Title

Steroid resistant rejection

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Steroid resistant rejection

Time Frame

1 year

Title

Liver function

Time Frame

1 year

Title

Calculated glomerular filtration rate

Time Frame

1 year

Title

Patient survival

Time Frame

1 year

Title

Number of days on renal replacement therapy

Time Frame

1 year

Title

Graft survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing primary liver transplantation. Patients older than 18 years. Patients with a hepatorenal syndrome. Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation. eGFR < 50 ml/min at the time point of transplantation. Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation. Exclusion Criteria: Patients with pre-transplant renal replacement therapy > 14 days. Patients with a reason for renal impairment other than a hepatorenal syndrome. Patients with a known hypersensitivity to mTOR-inhibitors. Patients with a known hypersensitivity to mycophenolate acid. Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies. Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition. Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition. Severe systemic infections and wound-healing disturbances. Multiple organ graft recipients. Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus. Pregnant women will not be included in the study. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule. Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aiman Obed, Prof. Dr.

Phone

+49 551 3912296

aobed@chirurgie-goettingen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Armin D Goralczyk, MD

Phone

+49 551 3914638

agoralczyk@med.uni-goettingen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aiman Obed, PD Dr.

Organizational Affiliation

University Medical Center Goettingen

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Armin D Goralczyk, Dr.

Organizational Affiliation

University Medical Center Goettingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Goettingen

City

Goettingen

ZIP/Postal Code

37099

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Armin D Goralczyk, Dr.

Phone

+49 551 398490

agoralczyk@med.uni-goettingen.de

First Name & Middle Initial & Last Name & Degree

Aiman Obed, PD Dr.

Phone

+49 551 39 12296

aobed@chirurgie-goettingen.de

First Name & Middle Initial & Last Name & Degree

Aiman Obed, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Armin D Goralczyk, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20380712

Citation

Goralczyk AD, Schnitzbauer A, Tsui TY, Ramadori G, Lorf T, Obed A. A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT. BMC Surg. 2010 Apr 9;10:15. doi: 10.1186/1471-2482-10-15.

Results Reference

derived

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

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