Safety Study of Hematide to Correct Anemia in Hemodialysis Patients
The purpose of this research study is to see if an experimental new drug called Hematideā¢ is safe and effective for the treatment of anemia in patients with Chronic Renal Failure who are on dialysis and are not taking any treatment to increase their red blood cell production (erythropoiesis).
Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with CKD Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life. Therefore, anemia should be diagnosed and treated early.
Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Hematide is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.
Subjects participating in this study will receive various doses of Hematide once every 4 weeks or Epoetin Alfa 3 times a week. Total commitment time of this study is a 4 week screening period followed by a minimum of 7 months of treatment.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematide, Hematide, Epoetin Alfa
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00680043
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).
A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
Chicken Anemia Virus
The type species of GYROVIRUS, a small, non-enveloped DNA virus originally isolated from contaminated vaccines in Japan. It causes chicken infectious anemia and may possibly play a key role in hemorrhagic anemia syndrome, anemia dermatitis, and blue wing disease.
To evaluate the safety and efficacy of Hematideā¢ in the maintenance treatment of anemia in hemodialysis patients.
To determine the dose ranges of Hematideā¢ administered intravenously (IV) or subcutaneously (SC) in hemodialysis (HD) patients previously treated with Epoetin.
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of Hematideā¢ in patients with chronic kidney disease (...
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of Hematide in patients with chronic kidney diseas...
The purpose of this study is to evaluate the safety, PK, and minimum pharmacologically active dose of Hematideā¢ in Healthy Volunteers.
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