Advertisement
Advertise here Publish your press releases here Sponsor BioPortfolio
Follow us on Twitter Sign up for daily news and research emails Contributors wanted

Safety and Efficacy of Hematide™ for the Correction of Anemia in Patients With Chronic Renal Failure (PEARL 2)

15:44 EDT 22nd July 2014 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of an experimental drug for the treatment of anemia in patients with Chronic Renal Failure (CRF), who is not on dialysis and not on Erythropoiesis Stimulating Agent (ESA) treatment.

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 variable doses of Hematide every 4 weeks or darbepoetin alfa every 2 weeks. Total commitment time for this study is 4 weeks of screening followed by a minimum of 52 weeks of study treatment.

Study Design

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

Conditions

Chronic Renal Failure

Intervention

Hematideā„¢, Darbepoetin Alfa

Location

Research Facility
Phoenix
Arizona
United States
85012

Status

Completed

Source

Affymax

Results (where available)

View Results

Links

Clinical Trials [1774 Associated Clinical Trials listed on BioPortfolio]

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...

Hematideā„¢ Injection for Anemia in Chronic Hemodialysis (HD) Patients

To evaluate the safety and efficacy of Hematideā„¢ in the maintenance treatment of anemia in hemodialysis patients.

Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia

Anaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous erythropiet...

Safety and Pharmacokinetics (PK) of Single Intravenous (IV) Doses of Hematideā„¢ in Healthy Volunteers

The purpose of this study is to evaluate the safety, PK, and minimum pharmacologically active dose of Hematideā„¢ in Healthy Volunteers.

A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for the Maintenance Treatment of Anemia in Kidney Transplant Recipients.

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic...

PubMed Articles [12650 Associated PubMed Articles listed on BioPortfolio]

Darbepoetin for the anaemia of chronic kidney disease.

Erythropoiesis-stimulating agents are used to treat anaemia in people with chronic kidney disease (CKD). Several agents are available including epoetin alfa or beta as well as agents with a longer dur...

Final results from the prospective phase III WSG-ARA trial: impact of adjuvant darbepoetin alfa on event-free survival in early breast cancer.

WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa (DA) on outcome in node positive primary breast cancer (BC).

Anemia and thrombocytopenia in acute and chronic renal failure.

Acute renal failure describes as a syndrome by rapid decline in the ability of the kidney to eliminate waste products, regulate acid-base balance, and manage water homeostasis. When this impairment is...

Acquired Perforating Dermatosis: A Report of 8 Cases.

Acquired perforating dermatosis (APD) is an uncommon disease characterized by lesions exhibiting transepidermal elimination of collagen or elastic fibers. APD affects adults and is associated with sys...

Kaposi sarcoma in a patient with chronic renal failure undergoing dialysis.

Kaposi sarcoma (KS) is a multicentric proliferative vascular tumor involving the skin and other organs. Human herpesvirus 8 (HHV-8) has been detected in KS lesions and is considered the putative causa...

Medical and Biotech [MESH] Definitions

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

A quinazoline-sulfonamide that is considered a thiazide-like diuretic which is long-acting so useful in chronic RENAL FAILURE. It also tends to lower BLOOD PRESSURE and increase POTASSIUM loss.

More From BioPortfolio on "Safety and Efficacy of Hematide™ for the Correction of Anemia in Patients With Chronic Renal Failure (PEARL 2)"

Search BioPortfolio: