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Nephrosis clinical trials

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NCT ID: NCT05588869 Not yet recruiting - Clinical trials for Steroid Dependent and Frequent Relapsing Nephrotic Syndrome

Cyclosporine Adverse Outcomes in Steroid Dependent and Frequent Relapsing Nephrotic Syndrome in Children;Single Center Study

Start date: October 20, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05392244 Not yet recruiting - Nephrotic Syndrome Clinical Trials

Characteristics of Peripheral Blood Lymphocyte Subsets in Children With PNS

Start date: May 30, 2022
Phase:
Study type: Observational

The etiology and precipitating factors of PNS remain unclear. Dysfunction of immunologic function is a classic theory of the pathogenesis of PNS. This study was aimed at investigating the characteristics of peripheral blood lymphocyte subsets and exploring its value of predicting infection in children with primary nephrotic syndrome (PNS).

NCT ID: NCT05301829 Not yet recruiting - Nephrotic Syndrome Clinical Trials

Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

TGANephrotic
Start date: April 1, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05044169 Not yet recruiting - Clinical trials for Nephrotic Syndrome in Children

Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

Start date: September 2021
Phase: N/A
Study type: Interventional

The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Broncho-Vaxom (administration for 6 months) may reduce the risk of subsequent relapse during 12-month of follow-up.

NCT ID: NCT04323007 Not yet recruiting - Thyroid Dysfunction Clinical Trials

Thyroid Dysfunction in Patients With Nephrotic Syndrome

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome

NCT ID: NCT04045171 Not yet recruiting - Pharmacokinetics Clinical Trials

Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome

PISTONS
Start date: August 10, 2019
Phase:
Study type: Observational

This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/ Pharmacodynamics (PK/PD) relationship of Tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.

NCT ID: NCT03235128 Not yet recruiting - Clinical trials for Nephrotic Syndrome Steroid-Resistant

Clinical Significance of Assesment of Serum miRNA-30a in Childhood Nephrotic Syndrome

Start date: October 1, 2017
Phase: N/A
Study type: Observational

Childhood nephrotic syndrome is the most frequent glomerular disease that presents during childhood,primarily owing to a disturbed immune function.This disease is characterized by alterations in selectivity at the glomerular capillary wall that lead to an inability to restrict the urinary loss of protein.

NCT ID: NCT03219684 Not yet recruiting - Clinical trials for Steroid Dependent and Steroid Resistent Nephrotic Syndrome

Cyclosporin A Therapy in Childhood Nephrotic Syndrome

Start date: April 1, 2018
Phase: N/A
Study type: Observational

Nephrotic syndrome (NS) is among the most common pediatric kidney diseases and is defined as massive proteinuria (>40 mg/m2/h or urine protein to creatinine ratio >2 g/g) leading to hypoalbuminemia (<2.5 g/dL), edema, and hyperlipidemia. 60-70 % of patients present prior to age of 6 years

NCT ID: NCT02649413 Not yet recruiting - Clinical trials for Nephrotic Syndrome, Minimal Change

Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome

AJSNS
Start date: March 2016
Phase: Phase 4
Study type: Interventional

The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the investigators will adjusted the first steroids does to the response day. Our primary end point is : a lower adjusted dose is as good as the fix dose in the first year after diagnosis.

NCT ID: NCT02216747 Not yet recruiting - Glomerular Disease Clinical Trials

Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

NS
Start date: September 2014
Phase: Phase 4
Study type: Interventional

Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well. Response to this treatment is the most important prognostic factor and this patients has a benign disease course. 60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration. guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion. Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?