Safety and Efficacy of Hematide� for the Correction of Anemia in Patients With Chronic Renal Failure (PEARL 2)
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
Hematide™, Darbepoetin Alfa
Location
Research Facility
Phoenix
Arizona
United States
85012
Status
Completed
Source
Affymax
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00598442
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Kidney Failure
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.
Renal Insufficiency, Chronic
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)
Renal Insufficiency
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).
Kidney Failure, Chronic
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.
Metolazone
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.
Clinical Trials
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 Hematide™ is safe and effective for the treatment of anemia in patients with Chronic Renal Failure who are...
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.
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 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.
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
Treatment of Anemia with Darbepoetin Alfa in Systolic Heart Failure.
Background Patients with systolic heart failure and anemia have worse symptoms, functional capacity, and outcomes than those without anemia. We evaluated the effects of darbepoetin alfa on clinical ou...
Anemia in chronic heart failure: Can we treat? What to treat?
Even though anemia is a significant comorbidity regularly observed in patients with chronic heart failure (HF), only in recent years systematic therapeutic research has been started. This article aims...
BACKGROUND: More strokes were observed in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) among patients assigned to darbepoetin alfa. We sought to identify baseline characteri...
Erythropoietic response and outcomes in kidney disease and type 2 diabetes.
BACKGROUND: Non–placebo-controlled trials of erythropoiesis-stimulating agents (ESAs) comparing lower and higher hemoglobin targets in patients with chronic kidney disease indicate that targeting of...
Heart failure: The end of the road for darbepoetin alfa in heart failure?
