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Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation (BASALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975663
Recruitment Status : Terminated
First Posted : September 11, 2009
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
University Hospital, Limoges

Tracking Information
First Submitted Date  ICMJE September 10, 2009
First Posted Date  ICMJE September 11, 2009
Last Update Posted Date April 26, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
Immunosuppressive treatment failure [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
  • Efficacy score [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
  • Toxicity score [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
  • Benefit/risk ratio [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
  • Each event composing the composite criterion [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
  • Overall cost of patients monitoring [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
  • Pharmacogenetic and proteomic analysis [ Time Frame: Day 7, day 14, day 21; months 3, 6 and every six months afterwards up to 3 years posttransplantation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation
Official Title  ICMJE Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis
Brief Summary The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dose adjustment of both drugs on the incidence of treatment failure over the first three years post-transplantation.
Detailed Description

This research will be based on a prospective randomized trial comparing optimized TDM of tacrolimus and MMF to the current strategy of tacrolimus and MMF dose adjustment in lung transplant recipients. The study will focus on the first three years post-transplantation, as treatment failures (including BOS) occur mainly during this post-transplantation period. As the aim of tacrolimus and MMF dose individualization is to avoid over- or underexposure, for the purpose of this study treatment failure will be a composite criterion gathering events which reflect both over- and underexposure to tacrolimus and MMF.

Optimized TDM of tacrolimus and MMF based on blood tacrolimus and plasma MPA AUC Bayesian estimation will be compared to current strategies: tacrolimus dose adjustment based on trough levels (C0) and administration of a standard dose of MMF, decreased by the pulmonologist in case of adverse drug reactions or increased in case of inefficacy. The efficacy of optimized strategy vs. current strategies will be mainly evaluated through the incidence of treatment failure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung and Heart-lung Transplantation
Intervention  ICMJE Drug: Tacrolimus and MMF
Tacrolimus: daily oral dose divided into 2 doses (morning and evening). MMF: daily dose divided into 2 doses at 12 hour intervals or 3 doses at 8 hour intervals.
Study Arms  ICMJE
  • Experimental: 1
    Optimized TDM of tacrolimus and MMF dosing
    Intervention: Drug: Tacrolimus and MMF
  • Active Comparator: 2
    Current tacrolimus and MMF dosing strategies
    Intervention: Drug: Tacrolimus and MMF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 10, 2009)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Male and female patients aged 18 years or more
  • CF and non-CF patients receiving single-lung or double-lung or heart-lung transplantation for the first time
  • Patients on oral tacrolimus and MMF for at least 48 hours at the time of inclusion (administration via a naso-gastric tube possible if necessary)
  • Patients without progressive chronic pathology jeopardizing short term patient and graft survival
  • Patients accepting to comply with at least the evaluation visits planned in the investigation center over the first three years post-transplantation (D7, D14, M1, M3, M6, M12, M18, M24, M30, M36)
  • Patients giving their free and informed written consent to participate in this study
  • Patients with a health insurance policy or registered under a health insurance program

Exclusion Criteria:

  • Patients aged less than 18 years or patients over 18 years under guardianship
  • Patients who disagree with this research
  • Patients with a contra-indication to receiving tacrolimus or MMF
  • Patients on cyclosporine, sirolimus or everolimus
  • Patients who have already benefited from a solid organ transplantation in the past (including lung or heart-lung transplantation)
  • Patients infected by Burkholderia cenocepacia (Burkholderia cepacia genomovar III)
  • Patients receiving HIV protease inhibitors (major pharmacokinetic interaction with tacrolimus)
  • Pregnant or breastfeeding women or those of child-bearing age who do not use an efficient contraceptive method
  • Drug users or patients suffering from neuro-psychiatric disorders preventing them from both proper comprehension of the protocol and reliable consent
  • Patients already participating in another interventional clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00975663
Other Study ID Numbers  ICMJE I07038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Marie SENGELEN, CHU Limoges
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Limoges
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pierre MARQUET, MD CHU Limoges
PRS Account University Hospital, Limoges
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP