Clinical Trials Logo
  1. Home
  2. Lung Transplantation
  3. NCT00930241

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

Lung Transplantation Clinical Trial

Official title:
Prospective Randomized Trial to Compare a Twice Daily to a Once Daily Administration of the Tacrolimus in Lung Transplanted Patients

Clinical Trial 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.

Clinical Trial Description

Prevalence data of non-compliance in solid organ transplantations fluctuate is reported in up to 39% of transplant recipients (z. B. for lung transplantations 13 - 22%; Kugler et al.). Non-compliance with immunosuppressive therapy is associated with an increased risk of late-acute rejections and the development of chronic transplant dysfunction. Chronic transplant dysfunction (bronchiolitis obliterans- syndrome-BOS) is the second most causing for organ failure after the first year following lung transplantation and often leads to re-transplantation or death. Preventative procedures for improving the compliance are simplification of the dose of the immunosuppressants (a once daily dose instead of a twice daily dose), the prescription of an immunosuppressants with less side-effects and to raise the patient´s awareness for having the greatest responsibility for the efficacy of his therapy. Prospective studies and metaanalysis revealed that the probability for a good compliance can be more than doubled at once daily administration in comparison to twice daily and the best predictor for a good compliance is an easy therapy. For this reason we want to investigate the extent of profit for our lung transplant patients receiving once daily basis immunosuppression in comparison to those who receive twice daily dose.

Hypothesis: Patients of the once daily administration group of the immunosuppressive medication will have a better compliance compared to the twice daily group (as measured by the endpoints variability and medication abstraction from the electronic devices) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00930241
Study type Interventional
Source Hannover Medical School
Contact
Status Terminated
Phase Phase 3
Start date July 2009
Completion date July 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT02581111 - Naloxone for Optimizing Hypoxemia Of Lung Donors Phase 2/Phase 3
Recruiting NCT02177916 - Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation N/A
Not yet recruiting NCT01394835 - Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients Phase 2
Not yet recruiting NCT01162148 - Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation N/A
Completed NCT01204970 - Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients N/A
Active, not recruiting NCT00980967 - Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study N/A
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Recruiting NCT00163696 - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease N/A
Completed NCT00177684 - Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®) Phase 3
Completed NCT00163891 - Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients N/A
Completed NCT03668483 - Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx N/A
Not yet recruiting NCT02855372 - Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT) N/A
Completed NCT01211509 - Montelukast in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT01212406 - Vitamin D in Bronchiolitis Obliterans Syndrome Phase 4
Not yet recruiting NCT00808600 - Empowerment of Lung and Heart-lung Transplant Patients N/A
Completed NCT00553397 - Live Lung Donor Retrospective Study N/A
Completed NCT00402805 - Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy Phase 4
Completed NCT00701922 - Surveillance Study of Viral Infections Following Lung Transplantation N/A
Terminated NCT00235651 - Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients Phase 3
Active, not recruiting NCT02936505 - Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD. N/A