A Phase 2/3 interventional study of Rituximab and Dexamethasone in Pharmacological Action, sponsored by Ain Shams University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
Prospective interventional comparative study to compare the efficacy of Rituximab versus Conventional treatment in Refractory Nephrotic Syndrome including patients on triple immunosuppression protocols.
A prospective randomized controlled interventional study, conducted on Refractory Nephrotic syndrome patients with failed different lines of conventional treatment.
The aim of the current study is to assess the therapeutic response of Rituximab versus Conventional treatment in Refractory Nephrotic Syndrome in terms of :
Fourty patients with Refractory Nephrotic syndrome will be enrolled in the study. All participants will be previously treated with ACEi and/or ARB, for ≥3 months prior to randomization and adequate blood pressure control. Participants will be assigned randomly into two groups with 20 Refractory Nephrotic syndrome patients in each group as follow:
The duration and severity of proteinuria are known to be surrogate markers of the progression of glomerular disease. Our approach to assess the clinical response was to evaluate estimated Glomerular filtration rate (eGFR), proteinuria and serum albumin after rituximab treatment. We classified the response into four stages :
A sample size of fourty patients with Refractory Nephrotic syndrome is selected to achieve confidence limit of 5%. At the end of the study, a number of data will be generated, such as:
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
Group (1) RTX in Refractory Nephrotic syndrome patients on conventional treatment (20 patients)
Also known as: Dexamethasone, Tacrolimus, Mycophenloatemofetil, Cyclophosphamide
Group (2) Refractory Nephrotic Syndrome patients on Conventional therapy (20 patients)
Also known as: Tacrolimus, Cyclosporine, Mycophenloatemofetil, Cyclophosphamide
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.
Time frame: 6 months
A) Late Remissions:
The first 6 months of the study will be considered the treatment period, while the remaining 6 months will be considered an observational period.So we will monitor the patients for CR or PR at 6, 9, and 12 months after randomization.
Time frame: 6, 9, and 12 months after randomization.
B) Relapse state:
Relapse state of the patient will be assessed at month 12 after randomization (Urine Protein (UP) \>3.5 g/24 h after earlier CR or PR).
Time frame: 12 months after randomization
C) Response Treatment Time:
The response time will be assessed by measuring the duration of clinical response to RTX in patients who had on going CR or PR.
Time frame: 12 months after randomization
D) End Stage Renal Disease (ESRD):
The patients who developed ESRD will be reviewed in this study.
Time frame: 12 months after randomization
E) Renal Function:
The effect of treatment on renal function will be assessed every 3 months by calculating the estimated GFR (eGFR) with the creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to 6 months.
Time frame: 6 months after randomization
F) Adverse events:
Patients will be educated about adverse effects of the drugs and will be required to report the occurrence of any of them.
Time frame: 6, 9, and 12 months after randomization.
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University