Kidney transplantation
Conditions
Interventions
Observation group (Patients undergoing kidney transplantation with immune induction using ATLG):None
Control group (Patients undergoing kidney transplantation induced by rATG immunization):None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The recipient is over 18 years old. 2.Has undergone allogeneic marginal donor kidney transplantation; Marginal donor kidneys must meet one of the following characteristics: 1) Age > 60 years old, or age 50-60 years old and meeting 2 of the following conditions: (1) Serum creatinine (Scr) level before donation > 1.5 mg/dL; (2) History of hypertension, died from hypertensive cerebral stroke; 2) Kidney donated at age 30 kg/m2; 4) Proteinuria > + in hypertension; 5) Diabetic nephropathy stage II or below; 6) Warm ischemia time of donated kidney 15-30 minutes, and cold ischemia time > 24 hours. 3.Received ATLG/rATG induction therapy during or after the transplantation procedure; 4.The subjects or their legal representatives voluntarily and strictly adhered to the requirements of the research protocol and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.The donor and recipient have incompatible ABO blood types. 2.Perform liver and kidney combined transplantation or pancreas and kidney combined transplantation; 3.Have a history of allergic reactions to any drugs or drugs of similar chemical category; 4.Pregnant or lactating women, as well as those with reproductive capacity who are unwilling or unable to take effective contraceptive measures; 5.The researchers evaluated other possible factors that could affect the conduct of the clinical study and the determination of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of biopsy-proven rejection reaction (BPAR) and the timing of the occurrence of the event;Subject mortality rate;The incidence rate of viral infections (such as CMV and BKV);The incidence of delayed graft function (DGF);Immune function test (CD4 and CD8 T lymphocyte counts); | — |
Countries
China
Contacts
Public ContactQinyan
Shanghai General Hospital
Outcome results
None listed