Rituximab on Adult-onset frequenTly rElApsing or steroid dependent nephrotic syndrome study - A-TEAM study

Isaka Yoshitaka0 sites64 target enrollmentSeptember 11, 2020

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Adult-onset frequently relapsing or steroid dependent nephrotic syndrome
Sponsor: Isaka Yoshitaka
Enrollment: 64
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

September 11, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Isaka Yoshitaka

•1\. patients with a previous diagnosis of frequently relapsing or steroid\-dependent nephrotic syndrome and urine protein \<0\.3 g/gCr in two or more urine protein quantitative measurements after starting steroid therapy for the most recent relapse
•(1\)Time of confirmation of urine protein \<0\.3 g/gCr
•1\) frequently relapsing nephrotic syndrome
•If a urine protein test of \<0\.3 g/gCr is found on 2 or more consecutive occasions with more than 1 day's clearance
•2\) Steroid\-dependent nephrotic syndrome
•If \<0\.3 g/gCr is found in the second urine protein test conducted more than 4 weeks after the first urine protein test and \<0\.3 g/gCr is found in the second urine protein test
•(2\)Definition of nephrotic syndrome, etc.
•1\)Nephrotic syndrome
•Proteinuria
•Urine protein to urine creatinine ratio of 3\.5 g/gCr or higher in urine at any time.

•1\. patients with secondary nephrotic syndrome (including suspected)
•Secondary nephrotic syndrome refers to nephrotic syndrome caused by IgA nephropathy, diabetic nephropathy, lupus nephritis, amyloid nephropathy, purpuric nephropathy, etc.
•2\. patients who have been treated with rituximab
•3\. Patients with an eGFR of 44 mL/min/1\.73 m2 or less
•4\. Patients suffering from malignancy
•(1\) Patients with an active malignancy or who have had a malignancy will be excluded. However, patients with a malignancy who are not prevalent, have not relapsed or flared up within 5 years prior to enrollment in the study, and have not been treated for malignancy (including land\-firming, maintenance and prophylactic therapies) will be eligible for enrollment in the study.
•(2\) Patients who have had intraepithelial cancer and who have been surgically cured, as determined by the attending physician, will be eligible for enrollment in the study.
•5\. patients with the following infectious diseases
•(1\) Patients with HIV (patients with confirmed positive HIV antibodies)
•(2\) Patients who are positive for one or more of the following antibodies: HBs antigen, HBs antibody, HBc antibody, and HCV antibody.