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Rituximab maintenance therapy in nephrotic syndrome

Phase 2
Conditions
Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Registration Number
CTRI/2022/02/040186
Lead Sponsor
Dr Arpita Raychaudhury
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1) Patients with idiopathic nephrotic syndrome with steroid

dependence or frequent relapses who has failed at least one steroid

sparing agent.

2) Secondary steroid resistant nephrotic syndrome with return of steroid sensitivity during treatment of relapse,failing at leat one immunosuppressant other than steroid.

3) In remission state or 24 hr urine protein < 1gm

4) Those who have given informed written consent

Exclusion Criteria

1) Primary steroid resistant nephrotic syndrome

2) Secondary cause of nephrotic syndrome

3) Genetic cause of nephrotic syndrome 4) Hepatitis B and C serology positive

5) Acute or chronic active infection

6) Chronic lung disease or uncontrolled asthma

7) Leucopenia or thrombocytopenia

8) ALT/AST >2.5 times upper limit of normal

9) Expected rituximab first infusion date less than 4 weeks from a live

vaccination

10) Regular follow-up not feasible

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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