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Anemia clinical trials

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NCT ID: NCT03056378 Withdrawn - Anemia Clinical Trials

POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units

Pooled RBCs
Start date: October 2019
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

NCT ID: NCT03055078 Recruiting - Aplastic Anemia Clinical Trials

Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic Anemia

Start date: January 2017
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in aplastic anemia.

NCT ID: NCT03054350 Completed - Anemia Clinical Trials

Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Start date: December 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).

NCT ID: NCT03054337 Completed - Anemia Clinical Trials

Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).

NCT ID: NCT03050268 Recruiting - Pancreatic Cancer Clinical Trials

Familial Investigations of Childhood Cancer Predisposition

SJFAMILY
Start date: April 6, 2017
Phase:
Study type: Observational

NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing. While it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition. The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer. PRIMARY OBJECTIVE: - Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members. SECONDARY OBJECTIVE: - Identify novel cancer predisposing genes and/or genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.

NCT ID: NCT03038633 Completed - Clinical trials for Iron Deficiency Anemia

A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia

Start date: May 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel medical food utilizing a nutritional strain of yeast for management of Iron Deficiency Anemia.

NCT ID: NCT03037164 Recruiting - Anemia Clinical Trials

INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections

RedeS
Start date: May 11, 2017
Phase: Phase 3
Study type: Interventional

Stage A: To evaluate the safety and efficacy of red blood cells (RBCs) prepared with the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in patients who require RBC transfusion support. Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in regions where a substantial proportion of the population has been infected or is at risk of a transfusion-transmissible infection. The objectives and design of Stage B will be reassessed on the completion of Stage A, in consultation with the FDA.

NCT ID: NCT03029247 Completed - Anaemia Clinical Trials

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

Start date: July 27, 2017
Phase: Phase 2
Study type: Interventional

This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD) participants with anemia associated with chronic kidney disease (CKD), designed to compare the effects of daprodustat to epoetin alfa on blood pressure (BP). Participants will be screened for eligibility within 7 and 30 days prior to erythropoesis-stimulating agent (ESA) washout. Following a 2-week ESA washout period, on Day 1 participants will be randomized 1:1 and stratified by prior ESA dose before they undergo Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest planned once-daily maintenance dose of daprodustat (24 milligrams [mg]) to the highest starting dose of epoetin alfa (100 units/kilogram [U/kg]). This will be followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on Day 57 an Acute Challenge 2 will be repeated utilizing the same treatment dose administered in Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing treatment.

NCT ID: NCT03029208 Completed - Anaemia Clinical Trials

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

Start date: May 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.

NCT ID: NCT03026751 Recruiting - Cytopenia Clinical Trials

Improving Diagnosis in Idiopathic Cytopenia Using Gene Sequencing

Start date: May 5, 2017
Phase: N/A
Study type: Observational

10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are for cytopenias. The hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have mutations in myelodysplasic syndrome (MDS)-associated genes. The investigators will sequence a panel of known MDS-associated genes in patient material (bone marrow and blood) that is sent routinely to the diagnostic service where conventional techniques have failed to establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to determine their survival, blood counts and development of acute leukaemia and other haematological malignancies. The clinical outcomes will be correlated with any mutations detected.