Advanced tertiary lymphoid tissues
Conditions
Interventions
methylprednisolone 500 mg intravenous administration for 3 days.
Kidney biopsy
365 +-45 days after steroid pulse therapy
Sponsors
Yanagita Motoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For primary enrollment, the following criteria must be met 1) Patients who have undergone living donor kidney transplantation in Japan 2) Patients scheduled to undergo protocol renal biopsy 1 year after kidney transplantation 3) 18 to 75 years old, and at the time of consent/enrollment date 4) Written consent has been obtained from the patient for study participation. For secondary enrollment, the following criterion must be met 1) Positive Advanced tertiary lymphoid tissues on renal biopsy 1 year after kidney transplantation
Exclusion criteria
Exclusion criteria: Patients will be excluded from primary enrollment if they meet any of the following criteria 1) Prior treatment with rituximab from perioperative to study enrollment 2) No improvement in renal function after kidney transplantation (eGFR = 7.5%) 8) Patients with poorly controlled glaucoma 9) Patients with poorly controlled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >= 100 mmHg) 10) Obesity (BMI >= 40 kg/m2) 11) History of fracture due to osteoporosis 12) History of severe drug allergy to steroids. 13) Women who are pregnant or may become pregnant. Women who are lactating. Patients will be excluded from secondary enrollment if they meet any of the following criteria 1) Diagnosis of acute rejection by renal biopsy 1 year after kidney transplantation. 2) Diagnosis of BK virus nephropathy by renal biopsy 1 year after kidney transplantation 3) Diagnosis of nephritis or other lesions requiring therapeutic intervention by renal biopsy 1 year after kidney transplantation 4) Patients who are judged unsuitable to conduct this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in presence/absence and stage of TLTs before and after 1 year of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Evaluate the change in Banff scores of biopsies before the treatment (immediately after kidney transplantation and during the first year of kidney transplantation) and one year after the treatment (two years after kidney transplantation) 2)Compare the rate of change in eGFR before the treatment (from 1 month after kidney transplant to the treatment) and after treatment intervention (from the treatment to 2 years after kidney transplant) 3)Compare the rate of change in eGFR before the treatment (from 1 month after kidney transplantation to the treatment) and after the treatment with the rate of change in eGFR in patients diagnosed with advanced tertiary lymphoid tissue in the previous study (unpublished data). 4)To confirm the safety of steroid pulse, blood glucose levels (fasting blood glucose, hemoglobin A1c) and dyslipidemia (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) will be compared before and after the start of treatment. In addition, the presence of adverse events such as femoral neck fracture will be checked. | — |
Contacts
Public ContactMotoko Yanagita
Kyoto University Hospital
Outcome results
None listed