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NEPHROSIS, LIPOID clinical trials

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NCT ID: NCT02592798 Completed - Nephrotic Syndrome Clinical Trials

Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Start date: March 9, 2016
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT02382874 Recruiting - Clinical trials for Focal Segmental Glomerulosclerosis

Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis)

Start date: May 2015
Phase: Phase 1
Study type: Interventional

Idiopathic Focal Segmental Glumero Sclerosis (FSGS) is not very common but important manifestation of kidney disease. FSGS has poor prognosis among the patterns of Idiopathic Nephrotic Syndrome (INS). Even with treatment (Steroid therapy and cytotoxic immunosuppressant therapy), many patients eventually still require dialysis. Cell therapy is useful in treatment of INS and mesenchymal stromal/stem cell is one of the cells that useful in the treatment of glomerulus disease. Intravenous injection of allogeneic adipose derived mesenchymal stromal/stem cell will be done in 5 patients with refractory INS(FSGS). They will be followed 1, 2, 4 weeks and then monthly until a year following injection day.

NCT ID: NCT01763580 Completed - Clinical trials for Minimal Change Nephrotic Syndrome (MCNS)

A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

T-OPTIMUM
Start date: July 16, 2012
Phase: Phase 4
Study type: Interventional

To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.

NCT ID: NCT01609426 Completed - Clinical trials for Idiopathic Nephrotic Syndrome

Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

NEPHROVIR-2
Start date: September 2012
Phase: N/A
Study type: Observational

The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

NCT ID: NCT01451710 Completed - IgA Nephropathy Clinical Trials

The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

Start date: March 2011
Phase: N/A
Study type: Interventional

This is a single center,prospective,no-controlled clinical trial

NCT ID: NCT01346007 Active, not recruiting - Clinical trials for Idiopathic Nephrotic Syndrome

Study of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

Start date: January 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine safely induces immune responses and immunological memory in children with idiopathic nephrotic syndrome in remission.

NCT ID: NCT01268033 Completed - Clinical trials for Childhood Idiopathic Nephrotic Syndrome

Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood

NEPHRUTIX
Start date: December 2010
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT01209000 Recruiting - Clinical trials for Membranous Nephropathy

Nephrotic Syndrome Study Network

NEPTUNE
Start date: April 2010
Phase:
Study type: Observational

Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients. In response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium. Through this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.

NCT ID: NCT01197040 Completed - Nephrotic Syndrome Clinical Trials

Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome

MSN
Start date: October 2009
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT01185197 Completed - Nephrosis, Lipoid Clinical Trials

Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

Start date: September 2010
Phase: Phase 4
Study type: Interventional

Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).