A single-arm pilot study to evaluate changes in renal function and safety of steroid pulse therapy in renal transplant patients with advanced tertiary lymphoid tissues

JRCT ID: jRCT1051210189

Registered date:08/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced tertiary lymphoid tissues
• Date of first enrollment: 18/05/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

methylprednisolone 500 mg intravenous administration for 3 days.
Kidney biopsy; 365 +-45 days after steroid pulse therapy

Outcome(s)

• Primary Outcome: Changes in presence/absence and stage of TLTs before and after 1 year of treatment

Secondary Outcome

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with the rate of change in eGFR in patients diagnosed with advanced tertiary lymphoid tissue in the previous study (unpublished data).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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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 < 30 ml/min/1.73 m2 ) until study enrollment
3) Previous diagnosis of BK virus nephropathy within 1 year after kidney transplant
4) Pathologically diagnosed with acute rejection within 1 year of kidney transplant
5) Patients who have received another organ transplant
6) Patients suffering from serious infections and other serious complications
7) Patients with poorly controlled diabetes mellitus (HbA1c >= 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.

Related Information

• Primary Sponsor: Yanagita Motoko