Assessment of Rituximab Therapeutic Response Versus Conventional Treatment

Conditions

• Pharmacological Action

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Rituximab — DRUG
  Group (1) RTX in Refractory Nephrotic syndrome patients on conventional treatment (20 patients)
• Dexamethasone — DRUG
  Group (2) Refractory Nephrotic Syndrome patients on Conventional therapy (20 patients)

Study Details

Prospective interventional comparative study to compare the efficacy of Rituximab versus Conventional treatment in Refractory Nephrotic Syndrome including patients on triple immunosuppression protocols.

Key Dates

Start date

Sep 25, 2022

Status verified

Sep 2022

Primary completion

Apr 1, 2023

Completion

Oct 1, 2023

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: RTX in Refractory Nephrotic syndrome patients on conventional treatment
  Refratory Nephrotic syndrome participants will receive a 375 mg/m2 weekly rituximab for four doses, with retreatment every 2 months till 6 months regardless of proteinuria response in addition to triple optimized immunosuppression therapy including steroids ± Calcineurine inhibitors (CNI) (e.g: Tacrolimus), Mycophenloatemofetil (MMF) and Cyclophosphamide (CTX)
• Active Comparator: Refractory Nephrotic Syndrome patients on Conventional therapy
  Nephrotic syndrome participants will receive conventional therapy treatment only including steroids ± Tacrolimus (TAC), Cyclosporine (CsA), Mycophenloatemofetil (MMF), and Cyclophosphamide (CTX) then if become refractory to conventional treatment will continue on the same treatment.

Primary Outcome Measure

The effectiveness of either conventional therapy alone or Rituximab as an add on therapy will be assessed by measure of Remission sate of the patient. [ Time Frame: 6 months ]