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Anemia clinical trials

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NCT ID: NCT02312414 Recruiting - Anemia Clinical Trials

Effects of Carnitine on Oxidative Stress to IVIR Administration to CKD Patients:Impact of Haptoglobin Genotype

Start date: October 2014
Phase: N/A
Study type: Interventional

Anemia is a common disorder in CKD patients. It is largely attributed to decreased erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3 genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far, there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in CKD patients. In this proposed study we wished to examine whether Hp genotype influences intravenous iron administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the response of these patients to L-Carnitine therapy.

NCT ID: NCT02310113 Completed - Anemia Clinical Trials

Transfusion and Skeletal Muscle Tissue Oxygenation

Start date: September 2013
Phase: N/A
Study type: Observational

The aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle StO2, and that the age of RBCs does not influence tissue responses. The investigators investigated these aspects using improved technology NIRS devices, for deeper tissue penetration and removal of the superficial signal from the skin.

NCT ID: NCT02300428 Completed - Anemia Clinical Trials

Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.

Start date: November 2014
Phase:
Study type: Observational

Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million prescriptions for oral iron are filled in England alone (NHS Information Centre data). However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron salts constitute the vast majority of currently prescribed oral iron because these are cheap and well absorbed. However, they are also poorly tolerated and thus, we believe, are expensive to the NHS. Funded by the Medical Research Council, we have developed an alternative oral iron supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy for IDA with minimal side-effects. In the study proposed here we aim to assess the total health cost associated with current oral iron supplements and, hence, define the clinical unmet need for alternative treatments. We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern of prescribing to oral iron in primary care in the general population and (ii) develop a health economics model in pre-menopausal women. These data will provide evidence for the total health system costs associated with current oral iron treatment. Furthermore, this study will provide data from which the cost-effectiveness and total health system costs of alternative effective and treatments with minimal side-effects could be estimated.

NCT ID: NCT02286154 Recruiting - Anemia, Sickle Cell Clinical Trials

Therapeutic Response Evaluation and Adherence Trial (TREAT)

TREAT
Start date: October 2014
Phase: N/A
Study type: Interventional

The primary objectives of this prospective study of hydroxyurea for children with sickle cell anemia are 1) Develop and prospectively evaluate a population pharmacokinetic/pharmacodynamics model to predict the maximum tolerated dose (MTD); 2) Identify urine biomarkers of hydroxyurea adherence using a novel metabolomics approach; 3) Identify pharmacogenomics modifiers of hydroxyurea MTD; and 4) Longitudinal monitoring of the effect of hydroxyurea upon organ function and quality of life.

NCT ID: NCT02282553 Completed - Clinical trials for Iron Deficiency Anemia

Gastric Capsule Examination for Iron Deficiency Anaemia

Start date: September 25, 2014
Phase: N/A
Study type: Interventional

This is a pilot prospective single blind controlled trial comparing magnetically steerable gastric capsule endoscopy to conventional oesophagogastroduodenoscopy in diagnosing upper gastrointestinal pathology in patients with recurrent/refractory iron-deficient anaemia.

NCT ID: NCT02278341 Completed - Anemia Clinical Trials

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Pyrenees
Start date: November 21, 2014
Phase: Phase 3
Study type: Interventional

This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

NCT ID: NCT02276690 Completed - Anemia Clinical Trials

Hepcidine and Iron Deficiency in Critically Ill Patients

HEPCIDANE
Start date: August 2014
Phase: N/A
Study type: Interventional

Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at admission and more than 80% at intensive care unit discharge. Iron deficiency is also frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care Unit, critically ill patients are exposed to repeated blood samples and to other blood losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since inflammation induces an increase in plasma ferritin levels and a decrease in transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The characterization of iron metabolism regulation by the hormone hepcidin opened new ways for the understanding and the follow-up of these complex clinical situations (combining inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker of iron deficiency in critically ill patients. To date, standard immunological methods of hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in the clinical setting because it is too expensive. New approaches for hepcidin quantification, based on mass spectrometry are proposed and may be routinely implemented. We make the hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment. The aim of this study is to evaluate the medical economic interest of a new diagnostic method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in critically ill anaemic patients.

NCT ID: NCT02273726 Completed - Clinical trials for CKD Anemia in Stable Dialysis Patients

Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis

Start date: January 15, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.

NCT ID: NCT02268994 Completed - Clinical trials for Anemia of Chronic Kidney Disease

KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

Start date: October 2014
Phase: Phase 3
Study type: Interventional

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

NCT ID: NCT02260193 Completed - Anemia Clinical Trials

16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

Start date: September 10, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.