Clinical Trials & Research

  • Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients

    The purpose of this study is to provide nephrologists with additional clinical evidenceregarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathicmembranous nephropathy. Approximately sixty (60) subjects will be randomized in thisdouble-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar andPlacebo administered 2 times per week for a 24-week treatment period followed by a 24-weekobservation period. The primary objective of this study is to assess the proportion oftreatment-resistant subjects (defined as subjects who either have had no response or havesuffered a relapse after achieving a partial response to their most recent standardtreatment regimen) who have a complete or partial remission of proteinuria in nephroticsyndrome due to idiopathic membranous nephropathy after 24 weeks of treatment.

    Investigator

    Now accepting new patients View Details

  • Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

    FSGS is an immunologic disorder wherein circulating immune proteins cause damage to thekidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but notnearly universally, successful in reducing proteinuria, and when patients respond, they havea favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) canprovide a more rapid, well tolerated reduction in glomerular injury.

    Investigator

    Not accepting patients at this time View Details

  • A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

    The primary objectives of this trial are as follows:

    - to compare the achievement of a partial remission (PR) or complete remission (CR) inurinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumabversus placebo

    - to compare the safety profile of patients treated with fresolimumab versus placebo

    The secondary objectives are as follows:

    - To compare the reduction in proteinuria in patients treated with fresolimumab versusplacebo

    - To evaluate fresolimumab dose-dependent reduction in proteinuria

    - To compare the change in renal function (estimated glomerular filtration rate [eGFR])in patients treated with fresolimumab versus placebo

    - To evaluate the multiple-dose pharmacokinetics of fresolimumab

    Investigator

    Now accepting new patients View Details

  • Nephrotic Syndrome Study Network

    Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranousnephropathy (MN), generate an enormous individual and societal financial burden, accountingfor approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annualcost in the US of more than $3 billion. However, the clinical classification of thesediseases is widely believed to be inadequate by the scientific community. Given the poorunderstanding of MCD/FSGS and MN biology, it is not surprising that the available therapiesare imperfect. The therapies lack a clear biological basis, and as many families haveexperienced, they are often not beneficial, and in fact may be significantly toxic. Giventhese observations, it is essential that research be conducted that address these seriousobstacles to effectively caring for patients.

    In response to a request for applications by the National Institutes of Health, Office ofRare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, anumber of affiliated universities joined together with The NephCure Foundation the NIDDK,the ORDR, and the University of Michigan in collaboration towards the establishment of aNephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.

    Through this consortium the investigators hope to understand the fundamental biology ofthese rare diseases and aim to bank long-term observational data and correspondingbiological specimens for researchers to access and further enrich.

    Investigator

    Now accepting new patients View Details

  • Rituximab in Progressive IgA Nephropathy

    Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis andother forms immune complex glomerulonephritis has led to its investigation in the treatmentof IgA nephropathy. Because IgA class antibodies have comparatively short half-lives andthat deposition of polymeric forms of IgA contributes to glomerular injury, we speculatethat the reduction of circulating IgA may reduce proteinuria and injury in patients with IgAnephropathy. Moreover, the absence of prospective trials in the treatment of IgA disease andthe lack of consensus for long-term treatment, the superior side-effect profile of this formof therapy may lead to significant advances in the treatment of this prevalent from ofglomerulonephritis.

    Investigators

    Now accepting new patients View Details