Intra-Patient Variability of Tacrolimus in Kidney Transplant Patients at Bhumirajanagarindra Kidney Institute Hospital

• Conditions: Kidney Transplant patients; Kidney; Transplantation; Tacrolimus; Variability

• Registration Number: TCTR20210519005
• Lead Sponsor: Bhumirajanagarindra Kidney Institute Hospital, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-19
• Study Completion: 2022-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. New kidney transplant patients who received living donor or deceased donor
2. Patients receiving tacrolimus as immunosuppression after transplantation

Exclusion Criteria

1. Patients with multiple organ transplantation
2. Patients having allograft with primary non-function
3. Patients having conditions affecting tacrolimus level
4. Incomplete information for study evaluation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-patient variability of tacrolimus 12 months after transplantation Intra-patient variability of minimum tacrolimus concentration

Secondary Outcome Measures

Name	Time	Method
Renal function 12 months after transplant eGFR by CKD-EPI equation,Rate of biopsy proven acute rejection (BPAR) 12 months after transplantation Diagnosis of BPAR by physician,Rate of infection 12 months after transplantation Diagnosis of any infection