Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

2014-08-27 03:53:05 | BioPortfolio


Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.

Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Kidney Disease







Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:53:05-0400

Clinical Trials [1592 Associated Clinical Trials listed on BioPortfolio]

Study to Evaluate Effectiveness of Aranesp®

The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients

The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in chronic kidney disease patients on dialysis.

Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.

Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis

The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinan...

A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and mai...

PubMed Articles [16242 Associated PubMed Articles listed on BioPortfolio]

The ABCs of chronic kidney disease.

Management of patients with chronic kidney disease has evolved since the last Kidney Disease Improving Global Outcomes clinical practice guideline was published in 2012. This article reviews the most ...

Chronic kidney disease and arrhythmias: highlights from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.

Gone but not forgotten: resolution of childhood kidney disease and the risk of end-stage kidney disease in adults.

APOL1: The Balance Imposed by Infection, Selection, and Kidney Disease.

Chronic kidney disease (CKD) affects millions of people and constitutes a major health and financial burden worldwide. People of African descent are at an increased risk of developing kidney disease, ...

Genomic approaches in the search for molecular biomarkers in chronic kidney disease.

Chronic kidney disease (CKD) is recognised as a global public health problem, more prevalent in older persons and associated with multiple co-morbidities. Diabetes mellitus and hypertension are common...

Medical and Biotech [MESH] Definitions

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)

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 complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

An autoimmune disease of the KIDNEY and the LUNG. It is characterized by the presence of circulating autoantibodies targeting the epitopes in the non-collagenous domains of COLLAGEN TYPE IV in the basement membranes of kidney glomeruli (KIDNEY GLOMERULUS) and lung alveoli (PULMONARY ALVEOLI), and the subsequent destruction of these basement membranes. Clinical features include pulmonary alveolar hemorrhage and glomerulonephritis.

KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE.

More From BioPortfolio on "Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis"

Quick Search


Relevant Topic

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Searches Linking to this Trial