Assessment of Rituximab Therapeutic Response Versus Conventional Treatment

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams University
• Treatments: BB 1101; Cyclophosphamide; Cyclosporine; Cyclosporins; Dexamethasone; Dexamethasone acetate; Rituximab; Tacrolimus

Criteria

Inclusion Criteria:

1. Adult ≥ 18 year old and medically stable.

2. Treatment with an Angiotension converting enzyme inhibitor (ACEi) and/or Angiotension II receptor blockade (ARB), for ≥3 months prior to randomization and adequate blood pressure control or if patient is intolerant to even a very low dose of either ACEi or ARB therapy.

3. Proteinuria ≥3 g/24 h using the average from two 24-hour urine collections collected within 14 days of each other despite ARB for ≥3 months as described above.

4. Estimated GFR ≥40 ml/min/1.73 m2 while taking ACEi/ARB therapy or quantified endogenous creatinine clearance ≥40 ml/min based on a 24 h urine collection.

5. Non responsive GN patients on conventional treatment.

Exclusion Criteria:

1. Autoimmune diseases.

2. Patients with presence of active infection or a secondary cause of IMN (e.g. hepatitis B, SLE, medications, malignancies).

3. Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy.

4. Pregnancy or breast feeding.

5. Predisposition to drug hypersensitivity.

6. Unstable medical condition.