NEWS HIGHLIGHTS
Published Studies Related to Versenate (Edetate Calcium Disodium)
Random serial sampling to evaluate efficacy of iron fortification: a randomized controlled trial of margarine fortification with ferric pyrophosphate or sodium iron edetate. [2010.11]
BACKGROUND: Random serial sampling is widely used in population pharmacokinetic studies and may have advantages compared with conventional fixed time-point evaluation of iron fortification. OBJECTIVE: Our objective was to validate random serial sampling to judge the efficacy of iron fortification of a low-fat margarine... CONCLUSIONS: When used to evaluate the efficacy of iron fortificants, random serial sampling can reduce the sample size, invasiveness, and costs while increasing sensitivity. Random serial sampling more clearly describes the pattern of iron repletion and may prove useful in evaluating other micronutrient interventions.
A randomised double-blind study comparing sodium feredetate with ferrous fumarate in anaemia in pregnancy. [2007.05]
Iron deficiency anaemia is a major health problem in India especially in women of reproductive age group. The World Health Organisation recommends that the haemoglobin concentration should not fall below 11.0 g/dl at any time during pregnancy... As there were no adverse effects reported with sodium feredetate, it can be concluded from this study that this new formulation appears to be effective in improving haemoglobin profile in pregnant anaemic women and is tolerated well.
Clinical Trials Related to Versenate (Edetate Calcium Disodium)
Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia [Recruiting]
This study will examine the use of a radioactive monoclonal antibody called yttrium
90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies
are genetically engineered proteins made in large quantities and directed against a specific
target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is
tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will
determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness.
Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and
lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be
eligible for this study. Candidates are screened with a medical history and physical
examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, CT scan or
ultrasound of the abdomen, PET scan of the neck and body, and skin test for immune
reactivity to antigens (similar to skin tuberculin test).
Before beginning treatment, participants may undergo additional procedures, including the
following:
- Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and
a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like
instrument.
- Patients with hearing loss have a hearing test.
- Patients with neurological symptoms have a lumbar puncture (spinal tap). A local
anesthetic is given and a needle is inserted in the space between the bones in the
lower back where the cerebrospinal fluid circulates below the spinal cord. A small
amount of fluid is collected through the needle.
- Patients who have not had a bone marrow biopsy within 6 months of screening also
undergo this procedure. The skin and bone at the back of the hip are numbed with a
local anesthetic and a small piece of bone is withdrawn through a needle.
Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be
safely given. The first group of three patients receives a low dose and, if there are no
significant side effects at that dose, the next three patients receive a higher dose. This
continues with subsequent groups until the maximum study dose is reached. 90 Y-HAT is given
through a vein (IV) over a 2-hour period. In addition, a drug called Ca-DTPA is given via IV
over 5 hours for 3 days to help reduce the side effects of the 90Y-HAT. In some patients,
the 90 Y-HAT may also be attached to a radioactive metal called Indium-111 to monitor what
happens to the injected material. During infusion of the drug, patients undergo PET scanning
to trace the path of the injected material in the body. For this procedure, the patient lies
in the scanner, remaining in one position during the entire infusion.
Blood and urine specimens are collected periodically over a 6-week period following the
infusion to determine the level of the radioactive antibody. Bone marrow, lymph node, or
skin biopsies may be done to determine how much of the antibody entered these sites.
Patients whose disease remains stable or improves with therapy may receive up to six more
infusions of 90 Y-HAT , with at least a 6-week interval between treatments.
Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies [Not yet recruiting]
RATIONALE: Antimicrobial solution comprising trimethoprim-sulfamethoxazole, edetate calcium
disodium, and ethanol may help prevent blockages and infections from forming in patients
with central venous access catheters or peripheral venous catheters.
PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in
maintaining catheter patency and preventing catheter-related blood infections in patients
with malignancies.
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection [Recruiting]
The primary purpose of this study is determine if a new formulation of Acetadote is at least
as effective as the current formulation in the prevention and treatment of acetaminophen
overdose related liver injury.
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency [Completed]
Previous study showed repeated lead chelation therapy significant reduced progressive renal
insufficiency in patients with chronic renal diseases and high-normal body lead burden in a
placebo-controlled, randomized, 2-year clinical trial, even factors that influence
progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary
protein excretion were well controlled. Since relative small sample size and short duration of
follow-up were noted in the previous study, whether repeated lead chelation therapy could
long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted
a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated
chelation in progressive renal insufficiency of patients with high-normal body lead burden.
Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation [Recruiting]
|
