Active clinical trials for "Nephrotic Syndrome"

It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).

To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents. Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.

Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease remission in SD-INS. Eligible participants will enter a 1-month run-in period, during which instruction on urine collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy with RAS inhibitors withdrawn and, in hypertensive children replaced by other anti-hypertensive drug. After run-in period, children will be randomized to either the intervention arm (Ofatumumab) or the comparator arm (Rituximab). After infusion of intervention or comparator, steroids will be maintained at initial dose for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal. One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and withdrawn within 2 additional weeks. All patients will be followed for up to 24 months. In case of relapses during the study (see outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in order to achieve remission. At remission, patients will be treated with another infusion of either Oftumumab or Rituximab, according to the initial randomization. After infusion of intervention or comparator, steroids will be maintained at initial dose for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal. One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses during the study.

A multicenter, randomized, study will be performed to evaluate the efficacy of low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly assigned to an open label treatment with either prednisone 1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The outcome will be compared during one-year follow up

Background Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine). Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern. Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect. Purpose The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome. Abstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.

This is a prospective open labeled trial examining the efficacy of ACTHar Gel (porcine ACTH) on the level of proteinuria in patients with diabetic nephropathy and nephrotic range proteinuria.

This study will examine the effectiveness of the drug pirfenidone in treating focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in the urine). About half of patients with FSGS eventually require kidney dialysis or transplant. Steroids, which are currently used to treat the disease, are effective in only a minority of patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in a very small percentage of patients and have serious side effects. Patients with FSGS who wish to participate in this study will undergo pre-study evaluation with blood and urine tests. Patients must be on a stable dose of an ACE inhibitor (a drug that lowers blood pressure and reduces proteinuria) for at list 6 months before starting pirfenidone therapy. (Patients who are not already taking an ACE inhibitor will be started on the drug; those who cannot tolerate ACE inhibitors will be given a different drug.) Patients with elevated cholesterol will take a cholesterol-lowering drug. A diet containing approximately 1 gram of protein per kilogram of body weight per day will be recommended. Patients will take pirfenidone by mouth 3 times a day for 12 months. Blood and urine will be tested once a month, either at NIH or by the patient's local kidney specialist. They will collect two 24-hour urine samples at the beginning of the treatment period, at 2-month intervals throughout the study, and at a 6-month follow-up. Patients will also be asked to give three to five tubes of blood and urine samples for analysis during the study. In animal studies, pirfenidone improved kidney function and proteinuria and reduced kidney scarring in rats with a disease similar to FSGS. In human studies, pirfenidone improved breathing and survival in patients with lung fibrosis.

The thromboembolic risk is increased during the nephrotic syndrome (NS) with an incidence of deep vein thrombosis 15%, pulmonary embolism of 10-30% and renal vein thrombosis of 25-37%. There is a hemostatic imbalance with urinary leakage of anticoagulant factors and increased hepatic synthesis of procoagulant factors, platelet hyperaggregability and a decrease in fibrinolytic activity. However, the identification of patients requiring anticoagulant prophylaxis remains imprecise.The thromboembolic risk is higher when the NS is related to extramembranous glomerulonephritis comparatively to others glomerulopathies. The reason of this difference is not still known. This risk increase with SN's severity and therefore with the decrease of albuminemia. Moreover, few studies have evaluated anticoagulant treatment efficacy during a NS, which clinical benefit depends also on hemorrhagic risk specific of each patient. Thus, the determination of the thrombotic risk and the modalities of anticoagulation are variable and perfectible during the NS. We propose to use the thrombin generation test (TGT) to quantify the thromboembolic risk in patients with a NS and to follow its evolution during prophylactic anticoagulation and after remission of NS.

The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.

This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of adult idiopathic nephrotic syndrome.