Safety Study of Calcineurin-Inhibitor-Free Immunosuppress... | NCT00890253

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

NCT00890253

Sponsor

Armin Goralczyk

Status

Unknown status

Last Update Posted

Sep 15, 2011Estimated

Enrollment

29Estimated

Phase

Phase 2

Conditions

Liver Transplantation
Chronic Renal Insufficiency

Interventions

Basiliximab (Simulect)
Myfortic
everolimus
Prednisolone

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Apr 28, 2009

First Submission Date that Met QC Criteria

Apr 28, 2009

First Posted Date

Apr 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2011

Last Update Posted Date

Sep 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CNI-free Immunosuppression	Experimental	Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.	Drug: Basiliximab (Simulect) Drug: Myfortic Drug: everolimus Drug: Prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Basiliximab (Simulect)	Drug	20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT	CNI-free Immunosuppression

Measure	Description	Time Frame
Steroid resistant rejection		30 days

Measure	Description	Time Frame
Steroid resistant rejection		1 year
Liver function		1 year
Calculated glomerular filtration rate

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Aiman Obed, PD Dr.	University Medical Center Goettingen	Study Director
Armin D Goralczyk, Dr.	University Medical Center Goettingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Goettingen	Recruiting	Göttingen		37099	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20380712	Derived	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D000077552	Basiliximab
D009173	Mycophenolic Acid
D000068338	Everolimus
D011239	Prednisolone
D011241	Prednisone

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins