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Sirolimus with reduced calcineurin inhibitor regimen in ABO incompatible kidney transplantation

Sirolimus with reduced calcineurin inhibitor regimen in ABO incompatible kidney transplantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0005271
Enrollment
80
Registered
2020-07-30
Start date
2020-07-17
Completion date
Unknown
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients will be randomized in a 1:1 ratio of standard-dose CNI/MPA (standard group) to reduced CNI/mTOR inhibitor (rapamune group) within 24 hours before transplantation. The target trough lev

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
binary composite of biopsy-proven acute rejection or eGFR,50 ml/min per 1.73 m2

Secondary

MeasureTime frame
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-?).

Countries

Korea, Republic of

Contacts

Public ContactHyunwook Kwon

Asan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026