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Anaemia clinical trials

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NCT ID: NCT03446612 Terminated - Anaemia Clinical Trials

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

Daprodustat has demonstrated an ability to effectively raise hemoglobin concentrations with lower erythropoietin (EPO) levels than those observed after administration of recombinant human erythropoietin (rhEPOs). Therefore, daprodustat has the potential to treat anemia of chronic kidney disease (CKD) with a lower cardiovascular (CV) risk than is observed with the rhEPOs. While the effect of rhEPOs on endothelial function has been assessed, to date the effect of daprodustat or other prolyl hydroxylase inhibitor (PHI) compounds on endothelial function has not. Therefore, the purpose of this study is to compare the effect of daprodustat to darbepoetin alfa on endothelial function by assessing FBF in participants with anemia of CKD by using venous occlusion plethysmography as a means to estimate the potential for daprodustat to have a lower risk of CV events as compared to rhEPO. This study will use a randomized, repeat dose, open label, parallel group design, in adult, not on-dialysis, male and female participants with anemia of CKD that are currently not treated with rhEPOs. The study will comprise of three study periods: a screening period starting up to 30 days prior to Day 1, a 42 day (6 week) treatment period, and a follow-up visit up to 14 days later. The total duration of participants involvement is up to 14 weeks (including screening and follow up visit). Approximately 50 participants will be randomized to either daprodustat or darbepoetin alfa.

NCT ID: NCT02801162 Terminated - Hypoxia Clinical Trials

Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard

Start date: September 2016
Phase: N/A
Study type: Interventional

Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing context.

NCT ID: NCT01406340 Terminated - Anaemia Clinical Trials

Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment

Start date: August 30, 2011
Phase: Phase 1
Study type: Interventional

This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent. GSK1278863 will be administered once daily for 14 days to normal subjects and subjects with Stage 3 and Stage 4 renal function, and 15 days to subjects with Stage 5 renal function. Pharmacokinetic assessments will be made on Days 1 and 14 (normal subjects, subjects with Stage 3 and Stage 4 renal function) or Days 14 and 15 (dialysis and non-dialysis days; Stage 5).

NCT ID: NCT01116479 Terminated - Cancer Clinical Trials

Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

HaemOPtimal
Start date: March 2010
Phase: Phase 2
Study type: Interventional

This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary end-point is quality of life

NCT ID: NCT00821717 Terminated - Clinical trials for Chronic Heart Failure

EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure

EFFICACY-HF
Start date: December 2008
Phase: Phase 3
Study type: Interventional

This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

NCT ID: NCT00259142 Terminated - Malaria Clinical Trials

Acceptability and Cost Effectiveness of Home Based Management of Fever: Different Strategies

Start date: November 2005
Phase: N/A
Study type: Interventional

Malaria remains a major cause of morbidity and mortality particularly among children < 5 years in Uganda. Due to inaccessibility many children die before they reach the health facility. The Home Based Management of Fever (HBMF) strategy was adopted in Uganda as a mean to improve access to early and appropriate treatment of fever at community level. Pre-packed chloroquine with sulphadoxine-pyrimethamine (HOMAPAK) is provided through Community Drug Distributors(CDDs). Initial evaluation showed underutilization of the CDDs (15%). This cast doubt on community acceptability, accessibility as well as its feasibility and cost effectiveness. This 3-year project intends to compare community acceptability and cost effectiveness of two HOMAPAK distribution methods. The current CDD-based HOMAPAK distribution versus home-based HOMAPAK distribution. The study hypothesis is that "home-based HOMAPAK distribution is more acceptable to the community and more cost effective than the CDD based HOMAPAK A non randomised community study will be conducted in two sub-counties of Mukono district. In the control arm, HOMAPAKs will be distributed through the CDDs while in the intervention arm, HOMAPAKs will be directly distributed to the caretakers in the homes. The study population are caretakers and their children < 5 years. At baseline a survey (Phase 1) with a sample size 657 in each study area will assess the common drugs stocked at home to treat malaria and the health seeking behaviour for malaria for children < 5 years and to determine the prevalence of malaria parasitaemia and anaemia among children < 5 years. Phase 2 includes the intervention. The villages will be assigned to either the control or intervention arm. Anaemia and malaria parasitaemia among children with fever will be assessed through active case finding. The impact of either distribution system on accessibility, acceptability, sustainability, compliance, cost effectiveness and malaria morbidity will be assessed during the evaluation phase. Health education messages on malaria prevention and treatment will be given to both communities. Drug misuse will be limited by distributing HOMAPAKs according to the number of children <5years in each household. HOMAPAK will only be replenished after the caretaker returns a used packet to the CDD.