Safety Study of Hematide to Correct Anemia in Hemodialysis Patients
Summary
The purpose of this research study is to see if an experimental new drug called Hematide™ 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).
Description
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Anemia
Intervention
Hematide, Hematide, Epoetin Alfa
Location
Research Facility
Irkutsk
Russian Federation
Status
Completed
Source
Affymax
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00680043
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Epoetin Alfa
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).
Interferon Alfa-2c
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.
Interferon Alfa-2a
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.
Interferon Alfa-2b
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.
Clinical Trials
Hematide™ Injection for Anemia in Chronic Hemodialysis (HD) Patients
To evaluate the safety and efficacy of Hematide™ in the maintenance treatment of anemia in hemodialysis patients.
Hematide™ Injection for Anemia in Chronic Hemodialysis (HD) Patients
To determine the dose ranges of Hematide™ administered intravenously (IV) or subcutaneously (SC) in hemodialysis (HD) patients previously treated with Epoetin.
Hematide™ Injection for Anemia in Chronic Hemodialysis (HD) Patients
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of Hematide™ 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...
Safety and Pharmacokinetics (PK) of Single Intravenous (IV) Doses of Hematide™ in Healthy Volunteers
The purpose of this study is to evaluate the safety, PK, and minimum pharmacologically active dose of Hematide™ in Healthy Volunteers.
PubMed Articles
Abstract Purpose. To evaluate the effects of epoetin alfa on patient-reported outcomes (PROs) in patients with breast cancer receiving myelotoxic chemotherapy. Materials and Methods. Women with hemogl...
PURPOSE: Following two cases of neutralizing antibodies to epoetin alfa in an investigational clinical study, a small number of individual syringes of two drug product batches we...
C.E.R.A. maintains stable hemoglobin in Latin American patients on dialysis.
BACKGROUND: C.E.R.A. is a continuous erythropoietin receptor activator with characteristics that permit a once-monthly schedule of administration for the maintenance treatment for chronic kidney disea...
Nadir Hemoglobin Levels after Discontinuation of Epoetin in Hemodialysis Patients.
BACKGROUND AND OBJECTIVES: In hemodialysis patients, both hemoglobin variability and targeting normalization of hemoglobin may have adverse consequences. There are few data on epoetin management in pa...
Methods for detection and confirmation of Hematide™/peginesatide in anti-doping samples.
Since the 1990's, cheating athletes have abused substances to increase their oxygen transport capabilities; among these substances, recombinant EPO is the most well known. Currently, other investigati...
