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Nephrosis clinical trials

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NCT ID: NCT05696977 Recruiting - Nephrotic Syndrome Clinical Trials

Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients

Start date: April 17, 2022
Phase: Phase 4
Study type: Interventional

This study aims to assess the effect of obesity on therapeutic response and safety of cyclosporine trough level in nephrotic syndrome patients and calculating a suitable weight-based dose.

NCT ID: NCT05687474 Recruiting - Cystic Fibrosis Clinical Trials

Baby Detect : Genomic Newborn Screening

Start date: September 1, 2022
Phase:
Study type: Observational

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

NCT ID: NCT05627557 Recruiting - Clinical trials for Childhood Idiopathic Nephrotic Syndrome

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

INShore
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

NCT ID: NCT05623033 Recruiting - Infections Clinical Trials

The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection

Start date: November 16, 2022
Phase:
Study type: Observational

The goal of this observational study is to test whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome . The main questions it aims to answer are: - whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome - effect of different immunosuppressive therapy on the number and function of T lymphocyte subsets in patients with primary nephrotic syndrome Participants will be divided into infection group and non-infection group according to whether they are infected

NCT ID: NCT05599815 Withdrawn - Nephrotic Syndrome Clinical Trials

Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome

Start date: January 2023
Phase: Phase 2
Study type: Interventional

A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome

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: NCT05588063 Recruiting - Clinical trials for Focal Segmental Glomerulosclerosis

taVNS for FRNS in Children

kidNEY-VNS
Start date: September 19, 2022
Phase: N/A
Study type: Interventional

Children with frequently relapsing nephrotic syndrome (FRNS) are exposed to prolonged courses of steroids and other immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated non invasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.

NCT ID: NCT05583942 Recruiting - Clinical trials for Focal Segmental Glomerulosclerosis

A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)

kidNEY-VNS
Start date: September 19, 2022
Phase: N/A
Study type: Interventional

Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.

NCT ID: NCT05505500 Recruiting - Fluid Overload Clinical Trials

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Prepare-NS
Start date: April 18, 2022
Phase:
Study type: Observational

Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome. Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.

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).