Clinical Trials NS

Immune System Related Kidney Disease
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov

Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney. It will attempt to provide information about the causes and specific abnormalities associated with autoimmune kidney disease. Patients with kidney disease as a result of their immune system, and patients with diseases of the immune system who may later develop kidney disease, will be potential subjects for this study. Patients will undergo a history and physical examination, and standard laboratory test to more closely understand the causes, signs, symptoms, and responses to medication of these diseases. Based on these evaluations the patients may qualify as candidates for other experimental studies. At any time these patients may be asked to submit blood or urine samples for further research. For more information...

Kidney Disease Biomarkers
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222; prpl@mail.cc.nih.gov

This study will identify biomarkers (proteins and other molecules in the blood or urine) that may help scientists predict what kidney disease a patient has and whether a given patient would respond to particular therapies. The study will look for biomarkers in the blood and urine of patients with various kidney diseases and study of the effects of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARB) on biomarkers. Blood and urine from healthy volunteers will be studied for comparison. For more information...

Retinoids for Minimal Change Disease and Focal Segmental Glomerulosclerosis
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222; prpl@mail.cc.nih.gov

Retinoids are analogues of vitamin A that regulate cellular differentiation, leading to therapeutic use in skin disease and malignancy. In animal models of kidney disease, retinoids restore podocyte phenotype (podocytes are specialized cells within the kidney involved in filtration) toward normal and reduce proteinuria (the loss of protein in the urine). The objective of this trial is to evaluate safety and develop preliminary evidence of efficacy of retinoid treatment in patients with podocyte disease including 10 adult patients with biopsy-proven minimal change disease, FSGS, or collapsing glomerulopathy. Inclusion criteria will include a prior trial of immunosuppressive therapy and proteinuria greater than or equal to 3.5 g/d while on angiotensin antagonist therapy. For more information...

Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
Collaborators: University of Michigan, St. John's Health System, University of Illinois, Wayne State
Principal Investigator: Roger C. Wiggins, MD University of Michigan
Contact: University of Chicago, Alberto Cabrales, 312-996-2937; acabrals@uic.edu
St. John's Health System, Sherry Gasko, 313-886-8787x 1264; sherry.gasko@stkohn.org
St. John's Health System, Tina Cavendish 313-886-8787x 1266; tcavendish@scsp.net
Wayne University, Carol Muzyk CCRP 313-745-2387 cmuzyk@med.wayne.edu
University of Michigan, Jennifer Hawkins 734-615-8304 jenjoyce@med.umich.edu
University of Michigan, Chrysta Lienczewski 734-615-5021 boridley@med.umich.edu

More than 10 million Americans have chronic kidney disease and every year, approximately 100,000 new patients develop end stage renal disease (ESRD) resulting in incalculable human suffering, a high rate of premature mortality, catastrophic physical and emotional disability and prohibitive costs to the U.S. health care system. The current medical therapies for chronic kidney disease, which disproportionately affect African Americans and other minority groups and account for 70% of ESRD, cases are woefully inadequate. This O'Brien Kidney Research Core will create opportunities for novel insights through characterization of tissue profiles that will define new disease markers and molecular pathways and will be available to all kidney investigators on the www. It will thereby fundamentally alter the starting point for research into prevention of progression of these kidney diseases. C-PROBE is an essential element of the center grant and presents a biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic identification of observable physical and biomedical characteristics) of kidney disease patients including the accurate measurement of kidney function; and (2) a specimen BioBank which will store blood, urine and kidney tissue samples.

A key component of C-PROBE is therefore that it contains a proven mechanism to collect samples from high risk groups including minorities, that will feed the other Cores and provide biomedical investigators at the institutions of University of Michigan Health System, St. John Hospital, Wayne State University in Michigan and University of Illinois in Chicago access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research. For more information...

Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy (MN)
Collaborators: Mayo Clinic, Questcor Pharmaceuticals
Principal Investigator: Fernando C Fervenza, M.D., Ph.D
Contact: Shirley Jennison 507-255-0231 jennison.shirley@mayo.edu
Lori Riess 507-266-1047 riess.lori@mayo.edu

This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Achtar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study. For more information...

Permeability Factor in Focal Segmental Glomerulosclerosis
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov

Focal segmental glomerulosclerosis (FSGS) is a renal syndrome characterized by proteinuria (usually nephrotic range), limited response to conventional therapy, and a poor renal prognosis, with progression to end stage renal failure in at least 50% of patients. As a syndrome, FSGS likely has many specific etiologies, only a few of which are well-defined. Recently, it has been suggested that some idiopathic FSGS patients have elevated circulating levels of a protein that induces glomerular permeability in vitro and in vivo. While there has been no consistent term for this factor, it will be termed here FSGS permeability factor (FPF). For more information...