Active clinical trials for "Nephrotic Syndrome"

This is an open-label Phase 2 study evaluating the long term safety and tolerability of GFB-887 in patients with focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD)

The proteinuria is widely recognized as a marker of kidney disease severity, as well as the predictor of renal function decline, cardiovascular outcomes, and all-cause mortality. However, the severity of kidney disease progression and these outcomes differs among patients with various amount of proteinuria. The potential mechanism underlining this disparity may be relevant to the quality and quantity of filtered proteins, especially their mechano-chemical properties such as physical viscosity and stiffness, amino-acid sequence, and molecular weight (low, middle and high molecular weight proteins). The goal of the current project is to develop and validate combined Brillouin & Surface-Enhanced Raman Scattering (SERS) Spectroscopy technique for simultaneous non-contact assessment of visco-elastic and chemical properties of urine proteins as biomarkers of kidney disease. Systematic studies of these properties of proteins in urine samples to be taken from diseased and healthy subjects will be cross-validated by Liquid Chromatography-Mass Spectrometry (LCMS). The project ultimately aims for the development of an optical spectroscopic sensor for rapid, non-contact monitoring of urine samples from patients in clinical settings.

The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.

The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered with atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.

Double-blind, two-parallel-arm, placebo-controlled randomized clinical trial testing the superiority of Ofatumumab versus placebo in the treatment of children with DR-INS. Participants will be stratified according to eGFR at enrollment. Eligible participants will enter a 3-months run-in period, during which instructions on urine collection and dipstick readings will be carefully reviewed, compliance assessed and any immunosuppressive therapies withdrawn according to the following schemes: prednisone will be tapered off by 0.3 mg/kg per week until complete withdrawal; calcineurin inhibitors and mofetile mycophenolate will be decreased by 50% and withdrawn after 2 additional weeks In order to minimize the risk of complications of uncontrolled INS a treatment with ACE-inhibitor at 6 mg/m2 will be maintained or started in all patients. After run-in period, children will be randomized to the intervention arm (Ofatumumab) or comparator arm (placebo). Randomization will be stratified by eGFR at randomization: ≥90 and <90 ml/min/1.73 m2. All patients will be followed up to 12 months and they will leave the study at time of relapse. Relapse will be defined as uPCR ≥2000 mg/g (≥200 mg/mmol) or ≥ 3+ protein on urine dipstick for 3 consecutive days.

Nephrotic syndrome (NS) is the most common glomerular disorder in children with significant morbidity and mortality and affects about 1-3 per 100,000 children aged below 16 years. Nephrotic syndrome is characterized by the presence of edema, proteinuria: uPCR (urine protein creatinine ratio) ≥200 mg/mmol (≥2 g/g) or 3+ protein on urine dipstick and hypoalbuminemia less than 3 g/dl).Nephrotic syndrome is classified according to response to steroids into steroid sensitive and steroid resistant. Approximately 90% of all cases are steroid-sensitive with an initial episode successfully treated with a standardized treatment protocol of steroids. However, about 80% of these patients experience further relapses. Of these, 50% are steroid dependent and frequent relapsers. While any relapse can be treated with steroids, children may be vulnerable to the side effects of a high cumulative dose of steroids such as obesity, growth impairment, behavioral alterations and attention problems, as well as reduced quality of life and family stress. To minimize steroid toxicity in patients with steroid-dependent and frequently relapsing nephrotic syndrome, a number of immunosuppressive agents are recommended as maintenance therapeutic agents. Among those are cyclosporine A, tacrolimus, mycophenolate mofetil (MMF), cyclophosphamide, levamisole and rituximab. Cyclosporin-A (CsA) is a calcineurin inhibitor that is well recognized as having a steroid sparing effect in steroid-dependent and frequently relapsing NS and has a role in the maintenance of complete remission in more than 75% of patients with SDNS during discontinuation of steroids. However, early withdrawl of cysclosporine may lead to relapses so the patient may be dependent on cyclosporine for years. The long-term use of CsA has been identified to be a risk factor of unsatisfactory effects such as nephrotoxicity, hypertension and cosmetic symptoms such as (gum hypertrophy and hirsutism). Therefore, close observation of the side effects of cyclosporine is very important as well as regular follow up of blood pressure and kidney function tests. Also, estimation of trough blood levels of CsA is required in patients with suspected non compliance, unsatisfactory response or nephrotoxicity (increase in serum creatinine by 30% or more from the baseline) aiming for the lowest levels that maintain remission and avoid toxicity (target 12-hr trough level of 60-150 ng/ml). Kidney biopsy could be included as a component of the long-term CsA protocol to test for CsA-associated nephropathy if given more than 2-3 years. CsA nephrotoxicity is primarily caused by chronic ischemic insult to the kidney, resulting in arteriolar hyalination and tubulointerstitial changes, including striped interstitial fibrosis, tubular vacuolization, and atrophy.The aim of this study is to determine the adverse outcomes of Cyclosporine in children with steroid dependent and frequent relapsing nephrotic syndrome in Sohag University Hospital.

The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic nephropathy: cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle. cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle. Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle. Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during the first cycle and progressively reduced during the subsequent cycles. The first cycle will be performed during hospitalization in the investigators Unit; subsequent cycles will be performed at nephrology outpatients. All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol, together with specific cellular values (Tregs, B cells, NK).

The purpose of this study is to determine whether using furosemide following acetazolamide is effective in treating refractory edema associated with nephrotic syndrome.

Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim of this study is to assess the efficiency of a 6-months levamisole course, given early after first remission, on maintaining a relapse-free course at 12 months.

In childhood nephrotic syndrome, the kidneys leak protein, causing body swelling and a variety of possible complications such as infection, blood clots, and kidney failure. The first-line treatment for nephrotic syndrome is corticosteroids. Many children respond to prednisone treatment, but the disease comes back (relapses) when the prednisone is stopped or the dose is reduced. Children with frequently relapsing or steroid dependent nephrotic syndrome are at risk for toxicity from frequent exposure to corticosteroids. Currently, the standard treatment for frequently relapsing and steroid dependent nephrotic syndrome involves a variety of medications that suppress the immune system, which can produce serious side effects. We propose a study to examine the effects of a different medication, ACTH, on nephrotic syndrome. ACTH is a hormone naturally found in the body. Recently, in adult studies, ACTH has been shown to be effective for the treatment of nephrotic syndrome. It has also been shown to have mild and reversible side effects. ACTH is potentially an attractive therapeutic alternative for the treatment of frequently relapsing and steroid dependent nephrotic syndrome in children. Our study will randomly assign patients with frequently relapsing or steroid dependent nephrotic syndrome to either ACTH treatment or no treatment. This will allow us to study the effects of ACTH on this disease and its side effects, by comparing how patients do on ACTH treatment versus no treatment. We hypothesize that ACTH gel is superior to no treatment in maintaining remission in children with frequently relapsing or steroid dependent nephrotic syndrome.