Twice Daily Versus Once Daily Administration of the Tacrolimus in Lung Transplantation

NCT00930241 | Terminated Phase 3

• 1 other identifier: 5281M mono
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a prospective randomized trial to compare twice daily to once daily administration of the basic immunosuppressive regimen in lung transplanted patients.

Conditions

Lung Transplantation

Keywords

Lung Transplantation; Tacrolimus; Deterioration of graft function

Outcome Measures

Primary Outcomes (1)

• Improvement of adherence as measured by Tacrolimus trough level below the target level and dispensing of less than 50% of the prescribed doses in the last three days measured electronically before this subtherapeutic drug monitoring

  6 months

Secondary Outcomes (2)

• Deterioration of graft function (FEV1) before and at month 12 after conversion

  6 months

• Number of drug holidays (intake of less than 50% of prescribed doses in 24 hours) measured electronically

  6 months

Study Arms (2)

Advagraf

EXPERIMENTAL

Advagraf® (one daily dose of Tacrolimus)

Drug: Advagraf®

Prograf

ACTIVE COMPARATOR

Prograf® (two daily doses of Tacrolimus)

Drug: Prograf®

Interventions

Advagraf® DRUG

Advagraf® (one daily dose of Tacrolimus)

Advagraf

Prograf® DRUG

Prograf® (two daily doses of Tacrolimus)

Prograf

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (Pts) more than 1 year after single lung, double lung or heart/lung transplantation
• Pts treated with cyclosporin, steroids and MMF
• Pts ≥ 18 and ≤ 70 years and
• Pts with one of the following:
• pts with recurrent acute rejections (RAR)
• two or more acute rejections in 3 months (first 3 years post Tx, 6 months (\> 3 years post Tx) defined by:
• transbronchial biopsy \> A1 (or A1 with clinical criteria below) nach ISHLT (B\>1R) or
• Pts with steroid-resistant or ongoing acute rejections (OAR) defined by:
• transbronchial biopsy \> A1 (or A1 with clinical criteria above) at least 4 weeks following steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) or
• Pts with CyA associated side effects (e.g., hyperlipidaemia, hypertriglyceridemia, hypertension, hirsutism, gingival hyperplasia)

You may not qualify if:

• Pregnant or breast feeding women
• Pts who are not using a double-barrier method of birth control
• Pts with systemic infections
• Pts with severe diarrhea, vomiting, active ulcer
• Pts with severe liver disease or liver cirrhosis
• Pts with m-Tor inhibitors
• Pts with hypersensitivity to Tacrolimus, other macrolides or other tablet ingredients

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (3)

Department of Respiratory Medicine, Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Hannover Medical School, Dept. of Respiratory Medicine

Hanover, 30625, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Jens T Gottlieb, M.D.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

DE (3)