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Clinical Trials/CTRI/2015/01/005364
CTRI/2015/01/005364
Recruiting
Phase 3

Efficacy and Safety of Rituximab to that of Calcineurin Inhibitors in Children with Steroid Resistant Nephrotic Syndrome

RS Medical College and Hospital0 sites120 target enrollmentTBD
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ConditionsHealth Condition 1: null- Nephrotic Syndrome

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Nephrotic Syndrome
Sponsor
RS Medical College and Hospital
Enrollment
120
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
RS Medical College and Hospital

Eligibility Criteria

Inclusion Criteria

  • •Children between 3 and 16 years with SRNS
  • •Minimal Change disease/MesPGN/FSGS as per Kidney Biopsy report.
  • •Estimated glomerular filtration rate (eGFR) \>80 ml/min per 1\.73 m2 at study entry.
  • •Not received any steroid sparing agent previously.
  • •Parents willing to give informed written consent.
  • •Ability to swallow tablet

Exclusion Criteria

  • •Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS)
  • •Patients with severe leucopenia (leucocytes \<3\.0Ã? 1000 cells/mm3\), severe anemia (haemoglobin \<8\.9 g/dl), thrombocytopenia (platelet \<100\.0 Ã? 1000 cells/mm3\) or deranged liver function tests (AST or ALT to \>50 IU/L ) at enrolment.
  • •Known active chronic infection (tuberculosis, HIV, hepatitis B or C)
  • •Live vaccination within 1 mo.

Outcomes

Primary Outcomes

Not specified

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Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic SyndromeNephrotic Syndrome
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