Prevention of acute allograft rejections in de novo lung allograft recipients MedDRA version: 12.0 Level: LLT Classification code 10051604 Term: Lung transplant rejection
Conditions
Interventions
Trade Name: CellCept 250 mg Capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mycophenolate mofetil
Current Sponsor code: RO 106-1443
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient received a primary single or bilat-eral lung allograft. 2. Primary reason for lung transplantation was cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or alpha-1 antitrypsin deficiency. 3. According to center practice patient re-ceives corticosteroids and cyclosporine as part of the immunosuppressive regime. 4. Patient is 18 years of age or older. 5. Patient is capable of understanding the purposes and risks of the study and is able to reliably report any adverse event. 6. Patient is willing to give written informed consent, written consent for data protec-tion and willingness to participate and to comply with the study. 7. Females of childbearing potential will have a negative pregnancy test at screening. 8. Patient agrees to utilize contraceptive methods throughout the study period, dur-ing treatment with mycophenolate mofetil and for 6 weeks following discontinuation of therapy 9. In general, women of childbearing potential should be using highly effective contraception to participate in clincial studies. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1 % per year) when used consistently and corrrectly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Retransplanted lung allograft recipients or multiple organ transplant recipients. 2. Patient has severe diarrhea or other gas-trointestinal disorder including biliary dis-ease interfering with his / her ability to ab-sorb oral medication. Cystic fibrosis is not an exclusion criterion. 3. Patient received an investigational new drug within the last 30 days. 4. Patient participates simultaneously in an-other clinical trial. 5. Patient participated in this study before. 6. Women lactating, pregnant or of childbear-ing potential not using a reliable contra-ceptive method. 7. Patient is underage or incapable to under-stand the aim, importance and conse-quences of the study and to give legal in-formed consent according to §40 Abs. 4 and §41 Abs. 2 and Abs. 3 AMG. 8. Patient has a history of psychiatric illness or condition such as to interfere with the patient´s ability to understand the require-ments of the study. 9. Patients who possibly are dependent on the sponsor or investigator. 10. Patient has exhibited in the past an allergic or other significant adverse reaction to my-cophenolate mofetil. 11. Patient has liver function test results greater than 3 times the upper limit of nor-mal (ULN). 12. Patient is positive for HIV or Hepatitis C. 13. Patient is positive for HBsAg and/or HBV-DNA. Inclusion of patients positive for anti-HBs and/or anti-HBc but negative for HBsAg and/or HBV-DNA is permitted. 14. Patients with malignancies or history of malignancy. 15. Patient has a current severe illness or any other condition(s) (e.g. psychiatric disor-der) which would make the subject in the opinion of the investigator unsuitable for the study. 16. Patient received prohibited medication as defined in section 4.5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate and compare pharmacokinetic parameters and meta-bolic ratios of mycophenolate mofetil in patients with cystic fibrosis (group A) and patients with chronic obstructive pulmonary disease (COPD), emphysema, idiopathic pulmonary fibrosis or al-pha-1 antitrypsin deficiency (group B). For the corresponding primary endpoints please refer to section main parameters in this synopsis. ;Secondary Objective: The secondary objectives of this trial are to evalu-ate algorithms for limited sampling strategies, to assess pulmonary function at day 90 post trans-plantation, to assess the patients´ alloimmune status and peripheral T-cell phenotype at baseline and days 4, 8, 20 and 90 post transplantation as well as safety aspects throughout the study period. For description of the corresponding secondary endpoints please refer to section main parameters in this synopsis. ;Primary end point(s): The primary objective will be evaluated by the as-sessment of the following parameters: • Maximum concentration (Cmax), dose nor-malized Cmax, time to maximum concentra-tion (Tmax), predose concentration (Cmin), volume of distribution (Vz), area under the curve 0-12 hours (AUC0-12) and dose-normalized AUC0-12 for MPA, MPAG, AcM-PAG and free MPA, at days 4, 8, 20 and 90 post transplantation for each patient in each group. | — |
Countries
Germany
Outcome results
None listed