Extended Release Tacrolimus on Intrapatient Variability in Kidney Transplant Recipients
Not Applicable
Recruiting
- Conditions
- Kidney transplantation.Kidney transplant statusZ94.0
- Registration Number
- IRCT20211221053480N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Kidney transplantation alone
At least 6 months post transplantation
Stable graft function
Stable Tacrolimus dosage
Coefficient variation of drug level >30%
On tacrolimus twice daily
Tacrolimus+MPA+prednisolone regime
Exclusion Criteria
History of acute rejection within 3 months
Active infection
Not willing to participate
Participating in other trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Coefficient variation of drug level. Timepoint: 3 months after conversion. Method of measurement: Drug level measurement with HPLC technique monthly and calculating coefficient variation.
- Secondary Outcome Measures
Name Time Method Graft function. Timepoint: 3 months after conversion. Method of measurement: GFR with creatinine based formula (CKD-EPI).