Kidney, Urologic and Hematologic Clinical Research
Clinical research is patient-oriented research. Research may be conducted in human
volunteers or on samples from humans. NIH-funded studies are carefully designed
to answer specific medical questions while protecting participants' safety. Well
conducted clinical trials are the fastest and safest way to find improved treatments
and preventions for diseases. Clinical trials or interventional trials determine
whether experimental preventions, treatments, or new ways of using known therapies
are safe and effective under controlled conditions. Observational or natural history
studies examine health issues and disease development in groups of people or populations.
Understanding Clinical Trials
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.
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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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Last Updated: 4/26/2006
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