NEWS HIGHLIGHTSMedia Articles Related to Conray (Iothalamic Acid Intravascular)
APA Leaders Defend New Diagnostic Guide
Source: MedPage Today Cardiovascular [2013.05.18]
SAN FRANCISCO (MedPage Today) -- The fifth edition of the "psychiatrist's bible" was officially released here in all its 947-page glory, with its developers offering a spirited rebuttal to their critics.
Topol on Using Smartphones for Complex Diagnostic Challenges
Source: Medscape Allergy & Clinical Immunology Headlines [2013.05.15]
Eric J. Topol, MD, describes how smartphones and supercomputers will partner to help clinicians with challenging medical diagnoses and treatments.
Medscape
FDA Approves New Lung Cancer Diagnostic "Cobas EGFR Mutation Test"
Source: Cancer / Oncology News From Medical News Today [2013.05.15]
The U.S. Food and Drug Administration (FDA) has approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC)...
Medical Diagnostic Device Employs Wireless Signals To Identify Brain Swelling Or Bleeding
Source: Medical Devices / Diagnostics News From Medical News Today [2013.05.15]
New technology developed at the University of California, Berkeley, is using wireless signals to provide real-time, non-invasive diagnoses of brain swelling or bleeding. The device analyzes data from low energy, electromagnetic waves, similar to the kind used to transmit radio and mobile signals...
FDA Approves Companion Genetic Diagnostic Test for Tarceva
Source: Medscape Today Headlines [2013.05.14]
The FDA has approved the first companion diagnostic test that can detect EGFR mutations in non-small cell lung cancer.
FDA Approvals
Clinical Trials Related to Conray (Iothalamic Acid Intravascular)
Evaluation of New Test Method to Measure Kidney Function [Completed]
This study will test the accuracy of a new "Fast GFR" (glomerular filtration rate) test to
evaluate kidney function. Accurate assessment of kidney function is important in many
clinical situations, including detecting kidney disease early, determining appropriate drug
dosages, deciding when to begin dialysis, and evaluating heart and kidney organ donors and
recipients. The current GFR test is used mostly for research purposes, as it is too costly
and complicated for general medical use. Another significant drawback to its use in
diagnosing acute kidney failure is the time it takes (3 to 24 hours) to complete, since
effective therapy for this condition requires its detection as soon as possible. The Fast
GFR, by comparison, takes only 45 minutes.
Patients 6 years old and older with kidney disease or with impaired kidney function caused by
abnormal heart function or swelling-from congestive heart failure, severe infections,
swelling from fluid accumulation, fluid in the abdomen, or burns-may be eligible for this
study. Patients will undergo both the standard and the Fast GFR tests, described below, to
evaluate the accuracy of the new test.
Fast GFR: Two catheters (thin flexible tubes) are placed into two arm veins, one for
injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the
other for collecting blood samples. Baseline blood and urine samples are collected and then
0. 5 milliliter (ml) iothalamate is injected into a vein. Blood samples are collected at 5,
10, 15, 20, 30, and 45 minutes in adults and at 5, 15, and 45 minutes in children. Urine is
collected at 45 minutes. The size of the bladder is measured using ultrasound to determine
if the bladder has completely emptied.
Standard GFR: Iothalamate (1 ml) is injected under the skin. Blood samples are collected at
60, 90, 120, 180 and 240 minutes. (A heparin lock is used to avoid multiple needle sticks.)
Urine is collected at 60, 90, 120, 180 and 240 minutes. The size of the bladder is measured
using ultrasound to determine if the bladder has completely emptied.
Kidney Disease Biomarkers [Recruiting]
Kidney Disease Biomarkers
Summary: 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.
Healthy people and the following patients may be eligible for this study: adults with
diabetic nephropathy 18 years of age and older; children with newly diagnosed clinical
idiopathic nephrotic syndrome between 2 and 18 year of age; children and adults with
glomerular disease (minimal change disease, focal segmental glomerulosclerosis, or
collapsing glomerulopathy).
Participants undergo tests and procedures as follows:
Glomerular Disease: Adults with glomerular disease provide about four to six blood and urine
samples over the course of 6 to 12 months. The samples are collected at the time of
regularly scheduled visits for the NIH treatment protocol in which they are participating.
Children provide only blood samples.
Chronic Kidney Disease: Patients with chronic kidney disease provide a blood and urine
sample every 6 months for 3 years or more.
Angiotensin Antagonism: Patients with chronic kidney disease who are taking ACE inhibitors
or ARBs stop their medicines for 4 weeks, while those who are not taking ACE inhibitors or
ARBs begin one of the medicines. In general, patients just starting on the medications
continue them after the study is completed, since they are beneficial for chronic kidney
disease.
- Medication withdrawal group: Patients come to NIH for 2 successive days at the
beginning of the study for blood and urine tests (including one 24-hour urine
collection) and to receive iothalamate (a chemical used to measure kidney function).
Iothalamate is delivered over 24 hours through a needle placed in the abdomen (or
elsewhere) via a pump similar to pumps that some diabetics use to deliver insulin.
Patients then stop taking their ACE inhibitor or ARB medication. They monitor their
blood pressure every day and return to NIH after 1, 2 and 4 weeks for blood tests.
During week 4, the iothalamate infusion is repeated, and blood and urine samples are
collected as at the beginning of the study. Patients then resume taking their ACE
inhibitor or ARB once a day with the dose being increased at 2-week intervals. They
come to NIH weekly after 1 week and then every other week for blood tests. Four weeks
after reaching the highest FDA-recommended dose of medication tolerated, the
iothalamate infusion and blood and urine collections are repeated.
- Medication induction group: At the beginning of the study, patients have the
iothalamate infusion and blood and urine collections described above and then begin to
take either an ACE inhibitor or ARB. The dose is increased after 2 weeks. Patients
monitor their blood pressure every day. After being on the highest dose for 4 weeks,
patients repeat the iothalamate infusion and blood and urine collections. The study is
then complete and they are provided a 2-month supply of medicine to take home.
Information is gathered on symptoms, treatments, and results of past laboratory tests of all
patients. Healthy volunteers provide blood and urine sample collections every month or every
other month for up to four collections to be used for biomarker studies and the screen for
common chronic diseases.
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients [Recruiting]
This study is being done to find out which treatment, tacrolimus or sirolimus, leads to
better long-term kidney function.
Pilot Study of Mycophenolate Mofetil in Congenital Uropathies [Completed]
Congenital or hereditary structural anomalies of the genitourinary tract account for
approximately half of all cases of end stage renal disease in the pediatric population.
Despite optimal medical management, when the GFR falls below 50 ml/min/1. 73 M2, nearly 40% of
affected children will require dialysis or a renal transplant within 2 years. At present,
there is no specific treatment for patients with congenital uropathies that can retard the
progressive loss of kidney function and forestall the need for renal replacement therapy.
There is evidence in experimental animals and in patients with chronic renal failure (CRF)
that immunoeffector mechanisms are activated within the renal parenchyma. Infiltration of the
kidney by macrophages, monocytes, and lymphocytes, activation of renal tubular epithelial
cells, and release of pro-inflammatory cytokines result in fibrosis and irreversible organ
damage.
Mycophenolate mofetil (MMF) is a new immunosuppressive agent that is used to prevent acute
rejection in kidney transplant recipients. It attenuates renal damage in the remnant kidney
model of CRF in which there is no primary immunological injury. Therefore, this pilot study
is designed to test the hypothesis that immunosuppressive treatment with MMF in children with
structural causes of CRF will be safely tolerated and that this therapy will retard
progressive decline in renal function.
Patients with congenital uropathy, 3-16 years of age and with a GFR less than 50 ml/ml/1. 73
M2, will be treated with MMF for 24 months. The two primary endpoints are: (1) safety and
tolerance of the drug; and (2) need for dialysis or kidney transplantation. It is anticipated
that the MMF will be free of significant toxicity and that administration of the drug will
reduce the frequency of progression to end stage renal disease from 38% to 19%. Patients will
be followed at 3-month intervals and they will undergo serial assessment of proteinuria,
estimated GFR and iothalamate clearance, urinary cytokine excretion, urine flow cytometry,
and immunologic testing.
The significance of this pilot study is that it may provide evidence in support of a
randomized, double-blind, placebo-controlled trial of immunological treatment of congenital
structural causes of CRF in children
Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Not yet recruiting]
This study is a prospective, randomized, placebo-controlled, clinical trial designed to
compare the effects of an agent that has antiproliferative (1,2), antiangiogenesis (3),and
tumor-progression blocking capabilities (4), namely, rapamycin (RapamuneŽ), in the treatment
of autosomal-dominant polycystic kidney disease (ADPKD).
Up to this time, only generic renal disease treatments for ADPKD have been in use, such as
the treatment of hypertension, urinary tract infections, renal stones, renal call
carcinomas, and replacement therapy with dialysis and/or renal transplantation. The
fundamental aberrations in ADPKD are proliferation of cyst-forming tubuloepithelial cells,
secretion of cytokine-rich fluid into those cysts, and progressive cyst expansion and
release of inflammatory mediators that injure surrounding normal renal tissue.
Consequently, therapy directed specifically at blocking the proliferation of
tubuloepithelial cells and their tendency to malignant transformation, as well as impeding
their blood supply, should have obvious merit.
General Procedures:
In Group I participants will have an iothalamate glomerular filtration rate (GFR) equal to
or greater than 60 ml/min/1. 73 m2, and in Group II participants will have a GFR less than
25-59 ml/min/1. 73 m2. Both males and females with ADPKD who volunteer and qualify, will be
randomly and prospectively assigned to treatment with rapamycin at either a high or low
trough blood level or to standard care (each 1/3 of enrolled patients) for one year. The
two treatment groups will receive rapamycin doses aimed at maintaining the 20- to 24-hour
trough blood levels at either 2 to 5 ng/mL (low-dose), or greater than 5 to 8 ng/mL
(high-dose). These trough levels are in the lower range of levels used when treating renal
transplant recipients in whom trough levels are typically maintained between 5 and 15
ng/mL.
|
