Pharmacological Action Clinical Trial
Official title:
Assessment of Rituximab Therapeutic Response Versus Conventional Treatment in the Management of Refractory Nephrotic Syndrome
Verified date | September 2022 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective interventional comparative study to compare the efficacy of Rituximab versus Conventional treatment in Refractory Nephrotic Syndrome including patients on triple immunosuppression protocols.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6, 9, and 12 months after randomization. | |
Secondary | 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). | 12 months after randomization | |
Secondary | 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. | 12 months after randomization | |
Secondary | D) End Stage Renal Disease (ESRD): | The patients who developed ESRD will be reviewed in this study. | 12 months after randomization | |
Secondary | 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. | 6 months after randomization | |
Secondary | 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. | 6, 9, and 12 months after randomization. |
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