Delayed CNI-based Immunosuppression With Advagraf After MELD-based Liver Transplantation

NCT01781195 | Unknown

• 1 other identifier: IMUTECT2013-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged-release low-dose Advagraf should better protect from CNI-side effects compared to standard immunosuppressive regiments while the rate of rejection is not increased and thus graft function is well maintained. We hypothesize that especially in high-MELD (MELD-score \>20) recipients who have a decreased immune competence the prolonged-release low-dose Advagraf concept would better protect from side effects of immunosuppression (i.e. infection). Nevertheless, we assume that also patients with a MELD-score ≤20 will benefit from this concept in regard to lower infection rates and less side effects of immunosuppression.

Conditions

Liver Graft Dysfunction

Keywords

Advagraf; MELD-score; Na-MELD-score; liver function; LiMAx-test; infection rate; HLA-DR status; immunostatus

Outcome Measures

Primary Outcomes (1)

• infection rate (CMV reactivation, wound infection, urinary tract infection, pneumonia)

  clinical visit: infection rate (CMV reactivation, wound infection, urinary tract infection, pneumonia)

  1-year follow-up per patient

Secondary Outcomes (2)

• liver function (LiMAx)

  one week

• HLA-DR status

  one week

Study Arms (1)

Advagraf-based immunosuppression

50 patients after liver transplantation (25 with a MELD-score ≤20 and 25 patients with a MELD-score \>20) under CNI-based immunosuppression with Advagraf

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with different MELD-scores/Na-MELD-scores undergoing liver transplantation

You may qualify if:

• age \>18, \<65
• first liver transplantation
• Immunosuppression with Advagraf, MMF, corticosteroid
• surgery and postoperative treatment at the department for general-, visceral- and transplantation surgery

You may not qualify if:

• missing informed consent
• re-transplantation
• acute infection: CMV (pp65 positive), pneumonia, urinary tract infection, wound infection, reactivation of Hepatitis B/C

Sponsors & Collaborators

• Heidelberg University: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

University Surgical Clinic

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

• Richter S, Polychronidis G, Gotthardt DN, Houben P, Giese T, Sander A, Dorr-Harim C, Diener MK, Schemmer P. Effect of delayed CNI-based immunosuppression with Advagraf(R) on liver function after MELD-based liver transplantation [IMUTECT]. BMC Surg. 2014 Sep 1;14:64. doi: 10.1186/1471-2482-14-64.

  PMID: 25178675 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood: HLA-DR status

Study Officials

• Peter Schemmer, Prof.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Schemmer, Prof.

CONTACT

+49-6221-566205; peter.schemmer@med.uni-heidelberg.de

Georgios Polychronidis, MD

CONTACT

+4962215637727; Georg.polychronidis@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (1)