The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

NCT01699360 | Unknown Phase 4

• 1 other identifier: H3110-81072700
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Immunosuppressive Agents; Hydrocortisone; Cortisone

Outcome Measures

Primary Outcomes (1)

• The relationship between the ratio of 6β-hydroxycortisol and 6β-hydroxycortisone to cortisol and cortisone in urine and pharmacokinetic parameters of immunosuppressive agents

  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.

  0-144h post-dose

Secondary Outcomes (1)

• The relationship between plasma 6β-hydroxylation clearance of the sum of cortisol and cortisone and pharmacokinetic parameters of immunosuppressive agents

  0-144h post-dose

Study Arms (1)

Cyclosporine A, Tacrolimus, Sirolimus

EXPERIMENTAL

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

Interventions

Cyclosporine A, Tacrolimus, Sirolimus DRUG

Cyclosporine A, Tacrolimus, Sirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The third xiangya hospital, Central South University

Changsha, Hunan, 410013, China

RECRUITING

Related Publications (1)

• Cai N, Li B, Huang X, Xu K, Feng H, Cheng Z, Zhu L, Zheng L, Luo X. A non-invasive CYP3A4 biomarker and body mass index predict cyclosporine dosage requirements in Chinese renal transplant recipients. Pharmazie. 2015 Dec;70(12):815-8.

  PMID: 26817280 DERIVED

MeSH Terms

Interventions

Cyclosporine; Tacrolimus; Sirolimus

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Zeneng cheng, doctor

  Central South University

  STUDY DIRECTOR

Central Study Contacts

Xi Luo, master

CONTACT

+86 731 2650451; luoxicsu@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical research assistant

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 3, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 3, 2012

Record last verified: 2012-09

Locations

CN (1)