Sirolimus with reduced calcineurin inhibitor regimen in ABO incompatible kidney transplantatio

Not Applicable

• Conditions: Not Applicable

• Registration Number: KCT0005271
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Recipients who underwent ABOi KT meeting all of the following criteria will be enrolled in the study
1) aged over than 18 years and less than 60 years
2) patients willing and able to give informed consent

Exclusion Criteria

• Patients who have not received other organ transplantation
• Patients with PRA (panel reactive antibody) test value > 50%
• Patients with DSA(Donor specific antibody) MFI test value >3000
• Patients with positive Lymphocyte cross-match
• History of malignancy of any organ system within 5years
• Patients with active infection
• Patients who received medication related with other clinical trials
• Patients who had follwing conditions
1) Severe uncontrolled hypercholesterolemia or hypertriglyceridemia
2) Abnormal liver function (AST, ALT, ALKP, total bilirubin) : more than three times higher than the standard value
3) White blood cell count =3,000 /mm3 (or absulute neutrophile count <1,000 mm3) or platelet count =75,000 /mm3

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
binary composite of biopsy-proven acute rejection or eGFR,50 ml/min per 1.73 m2

Secondary Outcome Measures

Name	Time	Method
graft loss, infectious complications, and the frequency of B, T cell, regulatory T cell, and associated cytokines (IL-2, IL-4, IL-10, IL-17A, TNF- ß, and IFN-?).