The Pharmacokinetic Study of Conversion Tacrolimus BID to Tacrolimus OD in Kidney Transplant Patient in King Chulalongkorn Memorial Hospital.
Completed
- Conditions
- Kidney transplant patient after 6 months of tranplanttacrolimus, pharmacokinetics, conversion, kidney transplant, 1:1
- Registration Number
- TCTR20210715002
- Lead Sponsor
- Ratchadaphiseksomphot Endowment Fund, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1.Post kidney transplant after 6 months or less than 10 years, 2. Mild to moderate immunological risk according to TTS (Thai Transplant Society), 3.Stable allograft function for the past 6 months by serum creatinie lesser than 3.0 mg per dL, 4. Currently on tacrolimus (BID TAC; Prograf, or OD TAC; Advagraf) no dose adjustment for 3 months
Exclusion Criteria
1.Pregnancy, 2.Suspicious for acute allograft rejection or history of past rejection, 3.Patient with abnormal liver function test or history of cirrhosis, 4.Patients with active infection or currentlt admission due to other medical conditions.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve at before and 4 weeks after medication conversion Trapezoidal model calculation,Tacrolimus whole blood concentration at time zero before and 4 weeks after medication conversion Chemiluminescent microparticle immunoassay
- Secondary Outcome Measures
Name Time Method rejection follow up till 1 year after medication conversion allograft kidney biopsy,allograft function by serum creatinine every 1-3 months follow up till 1 year after medication conversion routein blood check up at out patient clinic ,adverse reaction any time, follow up till 1 year after medication conversion patients self report outcome