The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

Phase 4 Unknown 600 enrolled Central South University

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2012-09
Primary completion: 2013-09
Completion: 2013-12

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	2 mg/kg	—
Subject	Cyclosporine	Peptide	6 mg/kg	—
Subject	Sirolimus	Small molecule	2 mg	—
Subject	Tacrolimus	Small molecule	0.15 mg/kg	—
Subject	Tacrolimus	Small molecule	0.3 mg/kg	—

Indications

No indication recorded.