View clinical trials related to Anaemia.
Filter by:The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study. The total duration of the study will be approximately 58 weeks including screening and follow-up.
The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or maintain the target Hgb levels. This study will consist of a 4-week screening period, a 24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period), and a 2- to 4-week follow-up period.
1. Burden: Anaemia is a public health problem in our country. Fifty one percent young children aged 6 to 59 months are suffering from anaemia in Bangladesh (BDHS-2011) and the main cause of this problem is iron deficiency. Research findings show that Iron deficiency leads to delayed development and even reduce working capacity. All these impact negatively on quality of life and loss of national gross domestic product (GDP). 2. Knowledge gap: Little is known about long-term effects of early life iron deficiency anemia on development and behaviour of children after correction with iron supplements. There is also scarcity of information if early life psychosocial stimulation added to iron supplementation to these anemic children have long term benefits compared to non-stimulated anaemic children or non-anaemic children 3. Relevance: The aim was to conduct a follow up study to examine whether the IDA children, who recovered from iron deficiency and received additional more intense psychosocial intervention catch up to their optimum development in later life at school age, similar like non-anaemic peers. 4. Hypothesis (if any): 1. The benefit of early iron supplementation in addition to Psychosocial stimulation on growth and development of IDA infants appears in later life. 2. Addition of early psychosocial stimulation in treated IDA children help them catch up to their non-anemic peers in development over time. 5. Study Objective(s) 1. To determine the long term effect of early psychosocial stimulation provided at the age of 6-24 months in addition to iron treatment in IDA children on their growth (height, weight and Head Circumference), IQ, executive function, school achievement, fine motor, memory and behaviour 2. To compare the growth and development of IDA infants with non-anemic infants after 7 years of an intervention with iron supplementation and psychosocial stimulation. 6. Methods: Sample: All children who participated in the iron and stimulation study at the age of 6 to 24 months (n=424). Identification of sample: Using the addresses and by tracking through available mobile phone numbers. Measurements In the current follow-up, at the age of around 8-9 years all the available children will be measured for: - WASI: The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - School achievement - Number Stroop - SDQ (strength and difficulties):The Strengths and Difficulties Questionnaire (SDQ) - Memory test of NEPSY (neuropsychological test) - Digit span forward and backward - Middle childhood HOME - Fine motor skills using the Purdue peg board or Movement Assessment Battery Children- 2 (age -band 2 for 7-10 years) - SES Anthropometric measurement: Children's height, weight and head circumference
This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects (Erythropoiesis-Stimulating Agent [ESA] users and ESA non-users) randomized to receive GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort 2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week treatment phase (including primary efficacy evaluation period [Weeks 40 to 52]), and a 4-week follow-up phase following the treatment phase. The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin (Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort 1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.
Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o
GSK1278863 is an orally available, hypoxia-inducible factor - prolyl hydroxylase inhibitor, currently being investigated as a treatment for anemia associated with chronic kidney disease. GSK1278863 has been given as a once daily regimen in clinical studies to date. However, physicians in countries that use a three-times weekly hemodialysis schedule prefer to give the anemia medicine at the same time as the dialysis session. This study will test how well GSK1278863 can maintain hemoglobin levels when given three-times weekly, for 29 days. This study will describe the relationship between hemoglobin and GSK1278863 given three-times weekly. The data from this study will allow for conversion of once daily doses to three-times weekly doses.
CAVIAR is a multicentre prospective observational study. Centres for cardiac and vascular surgery assess and manage patients in different ways before surgery. Some centres have introduced the use of intravenous iron therapy for patients with anaemia in the preoperative setting. Consequently regional variation exists in the assessment and management of patients before cardiac and vascular surgery. We aim to observe and measure these differing pathways and observe if there is variation in iron deficiency and anaemia and the impact of these variables on patient cardiorespiratory function as well as post-operative outcomes. [Sub-Study] For patients who are receiving intravenous iron therapy as part of their routine clinical care, we wish to observe this effect in more detail. We will assess the impact of the treatment on well-being, blood count and fitness. Information will be collected through Quality of Life questionnaires, total haemoglobin mass test (via blood collection) and fitness testing.