ew Possibilities of TDM of Cyclosporine A and its metabolites after kidney transplantatio
- Conditions
- patient on standart immunusupresive therapy with cyclosporine A after renal transplantation
- Registration Number
- EUCTR2005-004299-19-CZ
- Lead Sponsor
- niversity Hospital Ostrava
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 375
Inclusion Criteria
renal transplant patients on standart therapy with cyclosporine A
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
end of treatment with cyclosporine A, disagreement of patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The target of this project is to clarify the importance of TDM of CsA and its principal metabolites by LC-MS in lymphocytes when compared with currently used methods C through, AUC, and C2. ;Secondary Objective: We further wish for detection the role of the lipofile metabolite AM4N in imunosupresion and toxicity, and alternatively other metabolites analyzed by LC-MS.;Primary end point(s): to clarify the importance of TDM of CsA and its principal metabolites by LC-MS in lymphocytes when compared with currently used methods C through, AUC, and C2. We further wish for detection the role of the lipofile metabolite AM4N in imunosupresion and toxicity, and alternatively other metabolites analyzed by LC-MS.<br>to find the therapeutic range for safety and effective therapy with CsA
- Secondary Outcome Measures
Name Time Method