NCT00890253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

September 15, 2011

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

April 28, 2009

Last Update Submit

September 14, 2011

Conditions

Liver TransplantationChronic Renal Insufficiency

Keywords

Renal impairmentLiver transplantationChronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Steroid resistant rejection

    30 days

Secondary Outcomes (6)

  • Steroid resistant rejection

    1 year

  • Liver function

    1 year

  • Calculated glomerular filtration rate

    1 year

  • Patient survival

    1 year

  • Number of days on renal replacement therapy

    1 year

  • +1 more secondary outcomes

Study Arms (1)

CNI-free Immunosuppression

EXPERIMENTAL

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

Drug: Basiliximab (Simulect)Drug: MyforticDrug: everolimusDrug: Prednisolone

Interventions

Basiliximab (Simulect)DRUG

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

Also known as: Basiliximab: Simulect
CNI-free Immunosuppression
MyforticDRUG

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

Also known as: Enteric-coated mycophenolate sodium: EC-MPS, Myfortic
CNI-free Immunosuppression
everolimusDRUG

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

Also known as: Certican
CNI-free Immunosuppression
PrednisoloneDRUG

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

Also known as: Prednisone
CNI-free Immunosuppression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Goettingen

Göttingen, 37099, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20380712DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicRenal Insufficiency

Interventions

BasiliximabMycophenolic AcidEverolimusPrednisolonePrednisone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsSirolimusMacrolidesLactonesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediols

Study Officials

  • Aiman Obed, PD Dr.

    University Medical Center Goettingen

    STUDY DIRECTOR

  • Armin D Goralczyk, Dr.

    University Medical Center Goettingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiman Obed, Prof. Dr.

CONTACT

+49 551 3912296aobed@chirurgie-goettingen.de

Armin D Goralczyk, MD

CONTACT

+49 551 3914638agoralczyk@med.uni-goettingen.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

September 15, 2011

Record last verified: 2010-01

Locations

DE(1)