Randomized trial to establish a optimal treatment regimen of rituximab for adult refractory nephrotic syndrome

JRCT ID: jRCTs051180180

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: nephrotic syndrome
• Date of first enrollment: 10/11/2015
• Target sample size: 64
• Study type: Interventional

Intervention(s)

Group A: single dose of rituximab of 375mg/m2 (maximum 500mg) followed by additional single dose every 6 months.
Group B: double doses of rituximab of 375mg/m2 (maximum 500mg) followed by the same doses when CD19 positive cell is detected.

Outcome(s)

• Primary Outcome: Number of relapse (study period: 5 years)

Secondary Outcome

1) Duration of complete remission
2) Adverse effect (infusion reaction, anaphylaxis, infectious disease, progressive multifocal leukoencephalopathy, exacerbation of hepatitis and fulminant hepatitis by hepatitis B virus reactivation, skin or mucous membrane symptom, interstitial pneumonia, gastrointestinal perforation or obstruction)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have developed nephrotic syndrome at age less than 18 years old and have been dependent to steroid alone or a combination with calcineurin inhibitors.
2) Patients who have developed nephrotic syndrome at 18 years old or older and have been dependent or resistant to steroid alone or a combination with calcineurin inhibitors and have been complicated with adverse effects of these drugs (e.g., diabetes, morbid fracture).
3) Patients diagnosed by renal biopsy as having minimal change disease or focal segmental glomerulosclerosis.
4) Patients who are at least 20 years old when they give informed consent.

Exclude criteria

1) Patients diagnosed by renal biopsy as having any pathology other than minimal change disease or focal segmental glomerulosclerosis.
2) Patients with malignant disease or hematological disease.
3) Patients who are or may be pregnant, breast-feeding or hope to be pregnant during the study period.

Related Information

• Primary Sponsor: Hayashi Terumasa
• Secondary ID(s): UMIN000019844