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Clinical Studies


  • A Phase 2 Open-label Trial Evaluating the Efficacy and Safety of Daratumumab in Treatment of Patients with Active Lupus Nephritis Rochester, Minn.

    The purpose of this study is to assess the effectiveness and safety of daratumumab in inducing complete or partial remission in patients with active class III or IV (± V) lupus nephritis (LN) as measured by change in proteinuria and serum creatinine.




  • A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) (M-PLACE) Rochester, Minn.

    This is an open-label, multicentre study to characterize the safety and effectiveness of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory).

  • Biospecimens Resource for Glomerular and Tubulo-interstitial Diseases Rochester, Minn.

    This study is being done to create a "resource" of samples that can be used to improve our ability to diagnose and treat MN, IgAN, MPGN, FSGS/MCD, Lupus Nephritis, AAV, other glomerular tubulo-interstitial disease.

  • CureGN: Cure Glomerulonephropathy Network Rochester, Minn.

    Aim 1 (Epidemiology). To describe the disease trajectory under current clinical care; to estimate event rates for clinically meaningful outcomes; to identify patient characteristics (demographic, clinical, laboratory, environmental) associated with glomerular disease and non-renal complications of disease; to identify clinical predictors of short- and long-term outcomes, including therapeutic response; and to evaluate intermediate outcomes, such as proteinuria, as potential surrogates for longer-term outcomes.

    Aim 2 (Biomarkers). To identify and characterize clinical, histological, molecular, and genetic biomarkers that are linked to glomerular disease, disease outcomes, or that might be used to improve disease classification; to identify and characterize biomarkers that may be employed in clinical practice or clinical trials to predict disease trajectory, disease activity, or response to therapy.

    Aim 3 (Genetics). To understand the genetic architecture of the four glomerulopathies, including studies of germline sequence variation, somatic mutations, epigenetic changes, and transcriptomic profile, and their impact on disease presentation and clinical outcome; study gene-gene and gene-environment interactions that contribute to the development of the four glomerulopathies; and devise systems genetics approach to clarify pathogenesis.

    Aim 4 (PROs). To identify Patient Reported Outcomes (PROs, e.g., symptom burden, physical function, quality of life) associated with primary glomerular diseases; to validate disease-specific instrument(s) to assess the impact of disease and its therapy on patients; and to test the associations of PROs with disease progression.


  • Natural History Study of C3 Glomerulopathy: Discovery of Histological Predictors of Outcome Rochester, Minn.

    The aims of this study are to (1) determine the pathological spectrum of C3G, using clinical features available at diagnosis; clinical features over time; renal biopsy results at presentation and (where available) over time and (2) to determine if there are histological features within the renal biopsy that enable us to meaningfully stratify patients into prognostic groups.

  • The Nephrotic Syndrome Study Network Consortium (NEPTUNE) (NEPTUNE) Rochester, Minn.

    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.

Closed for Enrollment