Assessment of Rituximab Therapeutic Response Versus Conventional Treatment

NCT05553496 | Unknown Phase 2

• 1 other identifier: PHCL555
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary end point is Complete or Partial remission at 6 months after randomization. Complete remission (CR) is defined as UP ≤0.3 g/24 h and serum albumin ≥3.5 g/dl while Partial remission (PR) is defined as Reduction in baseline UP of ≥50% plus final UP ≤3.5 g/24 h but \>0.3 g/24 h. The patient who will be Non-responsive to therapy is defined as Reduction in baseline UP of \<25% (includes increase in UP) after 6 months of immunosuppression and the patient who will enter in the relapsed phase is defined as development of nephrotic range proteinuria following CR or PR, i.e. \>3.5 g/24 h.

  6 months

Secondary Outcomes (6)

• A) Late Remissions:

  6, 9, and 12 months after randomization.

• B) Relapse state:

  12 months after randomization

• C) Response Treatment Time:

  12 months after randomization

• D) End Stage Renal Disease (ESRD):

  12 months after randomization

• E) Renal Function:

  6 months after randomization

Study Arms (2)

RTX in Refractory Nephrotic syndrome patients on conventional treatment

ACTIVE COMPARATOR

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)

Drug: Rituximab; Drug: Dexamethasone

Refractory Nephrotic Syndrome patients on Conventional therapy

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Interventions

Rituximab DRUG

Group (1) RTX in Refractory Nephrotic syndrome patients on conventional treatment (20 patients)

Also known as: Dexamethasone, Tacrolimus, Mycophenloatemofetil, Cyclophosphamide

RTX in Refractory Nephrotic syndrome patients on conventional treatment

Dexamethasone DRUG

Group (2) Refractory Nephrotic Syndrome patients on Conventional therapy (20 patients)

Also known as: Tacrolimus, Cyclosporine, Mycophenloatemofetil, Cyclophosphamide

RTX in Refractory Nephrotic syndrome patients on conventional treatment; Refractory Nephrotic Syndrome patients on Conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 year old and medically stable.
• 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.
• 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.
• 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.
• Non responsive GN patients on conventional treatment.

You may not qualify if:

• Autoimmune diseases.
• Patients with presence of active infection or a secondary cause of IMN (e.g. hepatitis B, SLE, medications, malignancies).
• Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy.
• Pregnancy or breast feeding.
• Predisposition to drug hypersensitivity.
• Unstable medical condition.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Rituximab; Dexamethasone; Tacrolimus; Cyclophosphamide; Cyclosporine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Macrolides; Lactones; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical pharmacy department at Dar Al Fouad hospital

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 23, 2022
• Study Start: September 25, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09