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The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01699360
Recruitment Status : Unknown
Verified September 2012 by Xi Luo, Central South University.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Xi Luo, Central South University

Brief Summary:
The aim of this study is to evaluate the potential of endogenous cortisol and cortisone metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal transplant recipients. If the blood concentrations of immunosuppressants can be predicted successfully, this new probe may take place of current drug monitoring post transplantation.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Cyclosporine A, Tacrolimus, Sirolimus Phase 4

Detailed Description:
Immunosuppressive agents, including cyclosporine A, tacrolimus, and sirolimus, have been widely used to improve the outcome of organ transplantation. The need for frequent and specific monitoring of drug concentrations remains essential, since the therapeutic dosing and pharmacokinetics show great variability among recipients. However, this may be time and cost consuming. Indeed, cyclosporine A, tacrolimus, and sirolimus are all metabolized by CYP3A, consisting with the metabolic characteristic of endogenous cortisol and cortisone. Hence, the present study is designed to determine if the endogenous cortisol and cortisone metabolism can be used as an noninvasive probe for immunosuppressants pharmacokinetics in Chinese renal transplant recipients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Biomarker for CYP3A-mediated Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

    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.



Secondary Outcome Measures :
  1. 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 ]
    The same as in the Primary Outcome Measure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese adult patients who had undergone their first renal transplantation; All patients received an immunosuppressive regimen containing immunosuppressive agents, mycophenolate mofetil, and corticosteroids; All patients had normal liver and renal function.

Exclusion Criteria:

  • an acute rejection episode or infection; multiple organ transplantation; taking any other medications known to interact with immunosuppressive agents, with exception of calcium-channel blockers; abnormal findings on physical examination or laboratory tests.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699360


Contacts
Contact: Xi Luo, master +86 731 2650451 luoxicsu@yahoo.com.cn

Locations
China, Hunan
The third xiangya hospital, Central South University Recruiting
Changsha, Hunan, China, 410013
Principal Investigator: Xi Luo, master         
Sponsors and Collaborators
Central South University
Investigators
Study Director: Zeneng cheng, doctor Central South University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xi Luo, clinical research assistant, Central South University
ClinicalTrials.gov Identifier: NCT01699360     History of Changes
Other Study ID Numbers: H3110-81072700
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: September 2012

Keywords provided by Xi Luo, Central South University:
Kidney Transplantation
Immunosuppressive Agents
Hydrocortisone
Cortisone

Additional relevant MeSH terms:
Tacrolimus
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents