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
- Conditions
- Advanced tertiary lymphoid tissues
- Registration Number
- JPRN-jRCT1051210189
- Lead Sponsor
- Yanagita Motoko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in presence/absence and stage of TLTs before and after 1 year of treatment
- Secondary Outcome Measures
Name Time Method