Advertisement

Topics

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

2014-08-27 03:15:42 | BioPortfolio

Summary

This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

Description

There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hyperphosphatemia

Intervention

ferric citrate

Location

Westminster
Colorado
United States

Status

Recruiting

Source

Keryx Biopharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

Clinical Trials [295 Associated Clinical Trials listed on BioPortfolio]

Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These pat...

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of infla...

Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency

The main objective of the study is to compare the impact of oral ferric citrate compared to standard of care oral ferrous sulfate on serum iron, percent transferrin saturation, ferritin, h...

Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.

PubMed Articles [399 Associated PubMed Articles listed on BioPortfolio]

Safety and efficacy of ferric citrate in phosphate reduction and iron supplementation in patients with chronic kidney disease.

Ferric citrate has been reported to have the potential to reduce phosphate and increase iron availability in patients with chronic kidney disease. In the present study, we evaluated its safety and eff...

Fate of nanoparticles during alum and ferric coagulation monitored using single particle ICP-MS.

In this study, aluminum sulfate, ferric sulfate, ferric chloride, and poly(diallyldimethylammonium chloride) (pDADMAC) coagulation removal of citrate-stabilized silver and gold nanoparticles (NPs) and...

Liver injury induced by clomiphene citrate: A case report and literature reviews.

Clomiphene citrate is used to cause ovulation in females and to increase semen production in males. Clomiphene citrate is well tolerated in most patients and rarely induces liver injury. We report a c...

Effects of citrate on hexavalent chromium reduction by structural Fe(II) in nontronite.

Previous studies have shown that organic ligands could influence Cr(VI) reduction by aqueous Fe(2+) and pyrite. In this study, the effects of citrate on Cr(VI) reduction by structural Fe(II) in nontro...

Effect of Npt2b deletion on intestinal and renal inorganic phosphate (Pi) handling.

Hyperphosphatemia is common in chronic kidney disease and is associated with morbidity and mortality. The intestinal Na(+)-dependent phosphate transporter Npt2b is thought to be an important molecular...

Medical and Biotech [MESH] Definitions

A species of gram-positive, aerobic bacteria that causes granulomatous or ulcerating skin lesions in immunosuppressed persons. This organism owes its name to its requirement for growth of high levels of iron, conveniently supplied as blood, heme, or ferric ammonium citrate.

The reaction of potassium ferrocyanide with ferric iron to yield a dark blue precipitate at the sites of the ferric iron. Used to determine ferric iron in tissues, particularly in the diagnosis of disorders of iron metabolism.

An enzyme that, in the presence of ATP and COENZYME A, catalyzes the cleavage of citrate to yield acetyl CoA, oxaloacetate, ADP, and ORTHOPHOSPHATE. This reaction represents an important step in fatty acid biosynthesis. This enzyme was formerly listed as EC 4.1.3.8.

Enzyme that catalyzes the first step of the tricarboxylic acid cycle (CITRIC ACID CYCLE). It catalyzes the reaction of oxaloacetate and acetyl CoA to form citrate and coenzyme A. This enzyme was formerly listed as EC 4.1.3.7.

A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.

More From BioPortfolio on "A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturba...

Orthopedics
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial