The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients
Recruitment status was: Recruiting
Drug: Cyclosporine A, Tacrolimus, Sirolimus
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Biomarker for CYP3A-mediated Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients|
- The relationship between the ratio of 6β-hydroxycortisol and 6β-hydroxycortisone to cortisol and cortisone in urine and pharmacokinetic parameters of immunosuppressive agents [ Time Frame: 0-144h post-dose ] [ Designated as safety issue: No ]
For renal transplant recipients, blood samples are collected at 0 time point (before dosing) for the analysis of trough concentrations of immunosuppressive agents, and urine samples are gathered at 2h interval post-dose (8:00am-10:00am).
For healthy subjects, blood samples are collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h after cyclosporine A dosing; at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72h after tacrolimus dosing; at 0, 0.33, 0.67, 1, 2, 3, 4, 5, 8, 10, 12, 16, 24, 48, 72, 96, 120h after sirolimus dosing. Urine samples are obtained for 0-10 h (8:00 am to 18:00 pm) and 10-24 h (18:00 pm to 8:00 am) post-dose. Furthermore，blood samples at 1, 4, 8, 10, 24h and urine samples for additional 24 h interval (-8:00 am to 8:00 am) before dosing are compared with those obtained after dosing to evaluate the effects of immunosuppressive agents administration on cortisol and cortisone levels and metabolism.
- The relationship between plasma 6β-hydroxylation clearance of the sum of cortisol and cortisone and pharmacokinetic parameters of immunosuppressive agents [ Time Frame: 0-144h post-dose ] [ Designated as safety issue: No ]The same as in the Primary Outcome Measure
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Cyclosporine A, Tacrolimus, Sirolimus
Cyclosporine A：soft capsule,2-6mg/kg/d, the same twice daily dose at least five days.
Tacrolimus:capsule,0.15-0.3mg/kg/d, the same twice daily dose at least five days.
Sirolimus:tablet,2mg/d, once a day.
|Drug: Cyclosporine A, Tacrolimus, Sirolimus|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699360
|The third xiangya hospital, Central South University|
|Changsha, Hunan, China, 410013|
|Study Director:||Zeneng cheng, doctor||Central South University|