Kidney, Urologic and Hematologic Clinical Research

• Kidney Clinical Studies
• Urologic Clinical Studies

Kidney Clinical Studies

• Chronic Renal Insufficiency Cohort (CRIC) Study
  http://www.cristudy.org
  The purpose of this study is to determine factors that contribute to the decline in kidney function and the development of cardiovascular disease in people with chronic renal insufficiency.
  
  
• Continuation of AASK Cohort Study
  The Cohort Study is investigating environmental, socio-economic, genetic, physiologic, and other factors that influence progression of kidney disease in a well-characterized cohort of African Americans with hypertensive kidney disease.
  
  
• Dialysis Access Consortium (DAC)
  Maintenance of vascular access is one of the major challenges in the care of dialysis patients. Two clinical trials are studying the effects of anti-clotting agents.
  
  
• Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP)
  Established in March 1999, this 5-year, prospective cohort study will determine whether changes in anatomic characteristics of the kidneys as measured by radiologic imaging techniques will be useful in providing surrogate measures for PKD progression.
  
  
• Prospective Study of Chronic Kidney Disease in Children
  The goals of this prospective epidemiological study of children with chronic kidney disease are to determine risk factors for decline in renal function; incidence of and risk factors for impaired neurocognitive development and function; prevalence of risk factors for cardiovascular diseases; and long-term effects of growth failure and its treatment.
  
  
• Family Investigation of Nephropathy of Diabetes (FIND) Consortium
  Established to study the genetics of diabetic nephropathy, the consortium is the outgrowth of a 1998 workshop that identified as a high priority the delineation of genetic loci associated with the development and progression of diabetic and non-diabetic kidney disease. http://genepi.cwru.edu/FIND/
  
  
• Focal Segmental Glomerulosclerosis (FSGS) in Children and Young Adults Interventional Study
  Non-selective proteinuria is considered to be both a marker of glomerular injury and a risk factor for progression of kidney disease. A multi-center trial will examine the impact of therapy that modulates the immune system.
  
  
• Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT)
  This nationwide, multicenter clinical trial will determine whether total homocysteine-lowering treatment with a high-dose combination of folic acid, vitamin B12, and vitamin B6 reduces the rate of cardiovascular disease in stable renal transplant recipients with mild to moderately elevated total homocysteine levels. Currently Recruiting patients.
  
  
• Frequent Hemodialysis Clinical Trials
  Four centers will test whether it is feasible to randomize a representative sample of patients into either (a) conventional thrice-weekly dialysis treatments or (b) one of two forms of frequent dialysis: short daily dialysis or long nocturnal dialysis. Recruitment of patients is scheduled for fall 2004.
  
  
• Glomerular disorders, NIDDK Intramural Research Program
  Active research protocols at the NIH Clinical Center are recruiting patients with diabetic nephropathy, lupus nephritis, membranous nephropathy, minimal change disease, and focal segmental glomerulosclerosis
  
  
• Polycystic Kidney Disease (PKD) Clinical Trials Network
  Established in 2001, this network is developing pilot and feasibility trials; a large, randomized, controlled clinical trial (HALT PKD) on blockade of the renin-angiotensin axis; and a study of imaging techniques (CRISP) that may be helpful in determining disease progression in PKD. Not yet recruiting patients.
  
  
• United States Renal Data System (USRDS):
  Funded by the NIDDK in conjunction with the Centers for Medicare and Medicaid Services, the USRDS is a national data system that collects, analyzes, and distributes information about end-stage renal disease.

Urologic Clinical Studies

• Boston Area Community Health (BACH) Survey
  This epidemiologic study of a random sample of people in the Boston area will examine urological problems affecting the daily lives of Americans.
  
  
• Complementary and Alternative Medicine for Urological Symptoms (CAMUS)
  This research consortium, established in Fall 2002, will study two commonly used over-the-counter phytotherapies for BPH, saw palmetto and Pygeum africanum, to determine whether either or both prevent clinical progression of BPH.
  
  
• Chronic Prostatitis Collaborative Research Network (CPCRN)
  Data from an observational cohort of men with chronic prostatitis has provided further insight into the characteristics of this disease. A randomized, placebo-controlled clinical trial comparing treatment with Cipro and Flomax was initiated in the summer of 2001 and completed in spring 2003.
  
  
• Interstitial Cystitis Clinical Trials Group/Research Network
  The clinical trials group developed two randomized, controlled clinical trials of promising therapies, one using oral therapies, Elmiron® and Atarax® and the other administering intravesical treatment using a bacterium that stimulates the immune system. The ICCTG is also conducting ancillary studies of various biomarkers.
  
  
• Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for Benign Prostatic Hyperplasia
  New surgical treatments for BPH are being assessed for long-term safety and effectiveness.
  
  
• MTOPS Prostate Samples Analysis Consortium (MPSA)
  MPSA was established in 2002 to analyze serum and tissue samples collected in a large clinical trial, Medical Therapy of Prostatic Symptoms (MTOPS). Analysis of the samples will aid in the discovery of biomarkers for BPH and allow a biological evaluation of patients. News Release
  
  
• Urinary Incontinence Treatment Network (UITN)
  The UITN is conducting long-term studies of commonly used surgical, pharmacological, and behavioral approaches to managing stress and mixed urinary incontinence in women. The network is recruiting patients for a clinical trial of two surgical procedures: the sling procedure and the Burch procedure, which are commonly used to treat stress incontinence.
  
  
• Urologic Diseases in America Interim Compendium (UDA)
  NIDDK has established a national data system program that will collect, analyze, and distribute information about diseases of the bladder and other structures of the lower urinary tract. Data includes incidence, morbidity and mortality, outcomes, and economic health impact of these diseases as well as data on practice patterns in urology. The 2004 interim compendium of UDA covers urinary stones, urinary incontinence, urinary tract infections, benign prostatic hyperplasia, and sexually transmitted diseases. Still to come are chapters on perinatal hydronephrosis; male reproductive disorders; diseases of the urethra; kidney, bladder, and testicular cancer; and the pelvic pain syndromes interstitial cystitis and prostatitis.

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