NCT01068067

Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients

Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
OTHER	drug (tacrolimus and SchE) and genetics	Patients were genotyped for the polymorphisms that can influence tacrolimus pharmacokinetics before transplantation. After transplantation, initial tacrolimus dosage was based on an algorism guided by pharmacogenetics and SchE.
DRUG	tacrolimus	After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-12-01
• First posted: 2010-02-12
• Last updated: 2010-07-28

Locations

2 sites across 1 country: China