Iron Deficiency Anemia

Researchers are studying biomarkers from 129Xe gas exchange MRI to understand how they change with different medical interventions. The study focuses on interactions between 129Xe and red blood cells in the lungs. Participants include healthy volunteers and patients with conditions like interstitial lung disease, pulmonary hypertension, acute or chronic pulmonary embolism, anemia, polycythemia, and dyspnea. The study uses hyperpolarized xenon gas inhaled in multiple doses followed by breath holds, alongside oxygen administration. Participants are grouped by treatment: those undergoing transfusion or phlebotomy, patients receiving oxygen for lung-related conditions or healthy volunteers, and those recently diagnosed with acute or chronic pulmonary embolism. Treatments and responses are monitored at baseline and various follow-up points. Participants will undergo MRI scans to measure red blood cell transfer, chemical shifts after oxygen delivery, and changes in red blood cell signal oscillations before and after treatment. The study includes visits up to 3–6 months after interventions to track changes. Researchers also monitor safety and participant adherence throughout the study, which lasts until mid-2028.

Researchers are evaluating a new combination of evidence-based interventions (EBIs) aimed at improving diagnostic safety and efficiency in primary care for patients with anemia and decreased glomerular filtration rate. The study is designed as a stepped wedge cluster randomized control trial to measure how these interventions affect patient safety and healthcare efficiency, while also assessing factors influencing their implementation such as acceptability, cost, and sustainability. The study compares an enhanced diagnostic team approach to usual care. The enhanced approach includes automated detection and tracking of abnormal test results, expanding the primary care team to include clinical pharmacists to guide anemia evaluation, and engaging patients through nurse navigators to increase their activation in the diagnostic process. The study involves several clinic groups that receive the intervention at different times, ranging from 12 to 24 months, with some initial control periods. Participants will have their diagnostic accuracy for causes of low hemoglobin and decreased glomerular filtration rate assessed within six months. Researchers will track time to diagnosis, appropriate test usage, treatment costs, and primary care physicians' views on the intervention's acceptability and feasibility. The study also monitors how well the diagnostic process steps are followed, the intervention's reach among patients, and sustainability in clinics over 2.5 years. Patient activation and clinic-level facilitators and barriers are evaluated through surveys and measures during the study period.

This research aims to evaluate how human lactoferrin combined with low-dose iron affects iron levels, aerobic fitness, and lactate metabolism in women who exercise and have low iron stores. The study focuses on healthy menstruating women aged 18 to 45 years with serum ferritin below 35 g/L, aiming to understand if lactoferrin can improve iron regulation and exercise outcomes. Iron deficiency is common in active women and can reduce oxygen delivery and exercise performance, making this study important for finding better supplementation methods. Participants will be randomly assigned to one of three groups for an 8-week period: receiving 100 mg lactoferrin plus 5 mg iron daily, 300 mg lactoferrin plus 5 mg iron daily, or a placebo plus 5 mg iron daily. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment. The intervention is oral supplementation taken daily, and participants will attend six visits including screening, baseline, and follow-ups at weeks 2, 4, 6, and 8. During the study, participants will undergo blood tests to measure iron biomarkers and blood parameters, along with assessments of aerobic capacity using treadmill tests measuring VO2peak, time to exhaustion, and blood lactate levels. Questionnaires will evaluate gastrointestinal symptoms, menstrual symptoms, quality of life, and recovery perception. Daily supplement adherence and any side effects will be monitored throughout. The primary outcome is the change in serum ferritin concentration over time, while secondary measures include changes in hemoglobin, hematocrit, red blood cell count, and exercise performance indicators.

Researchers are evaluating the effects of a dietary supplement on blood-based nutritional biomarkers in healthy children aged 4 to 15 years. This pilot clinical study aims to gather preliminary data on how the supplement influences serum levels of vitamin D, vitamin B12, folate, omega-3 fatty acids, and other blood count parameters. The study is conducted by SF Research Institute, Inc. and focuses on understanding nutritional status through biomarker changes. The study involves a single group of participants who will take an investigational gummy dietary supplement called Kids Multi & Omegas. Children will be instructed to take two gummies once daily, with or without food, for a total of 4 weeks. Blood samples will be collected at the start and end of the study to assess changes in selected serum nutritional biomarkers. Participants will also undergo measurements of height, weight, and body mass index, and complete a socioeconomic questionnaire. Participants will attend two clinic visits: one for screening and baseline assessments and another at the end of the 4-week supplementation period. During the study, children or their caregivers will keep a daily diary recording supplement intake, medication use, and any side effects. Researchers will review compliance, collect blood samples, and assess changes in nutritional biomarkers and physical measurements. The total study duration for each participant is approximately 4 weeks.

Researchers are investigating whether the amount of iron in tears is connected to the severity of dry eye disease. This observational study compares tear samples from people with dry eye to those from individuals with healthy eyes. The goal is to find new ways to diagnose and understand dry eye by analyzing tear iron levels alongside standard dry eye test results and symptom scores. Participants will have a single study visit involving tear fluid collection using sterile Schirmer test strips without anesthesia, placed in the lower conjunctival sac for 5 minutes. They will also undergo a detailed eye surface evaluation, including the Ocular Surface Disease Index questionnaire and clinical tests such as fluorescein tear film breakup time, corneal fluorescein staining scoring, and Schirmer I test. The tear samples will be analyzed for iron concentration. During the study visit, researchers will assess symptoms and conduct clinical tests to measure tear film stability, tear secretion volume, and corneal epithelial damage. The main measure is the correlation between tear iron levels and dry eye symptom severity. This single diagnostic visit includes no treatment, and participants' usual eye care remains unchanged. The study is expected to continue until May 2029.

Researchers are evaluating elritercept compared to epoetin alfa to treat anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to assess how elritercept affects the need for RBC transfusions, its safety, and whether it improves tiredness and quality of life compared to epoetin alfa. The trial also explores the immune response to elritercept and monitors medical problems related to the treatment. Participants will be randomly assigned to receive either elritercept or epoetin alfa. Those receiving elritercept will start with a dose of 3.75 mg/kg by subcutaneous injection every 4 weeks, which may be increased to 5.0 mg/kg if necessary. Participants receiving epoetin alfa will start at 450 IU/kg by subcutaneous injection once weekly, with possible dose escalation up to 1050 IU/kg. Treatment will continue with monitoring over several cycles, each lasting 28 days, with assessments up to 48 weeks and potential follow-up to about 5 years. During the study, participants will have regular visits to assess their need for RBC transfusions, hemoglobin levels, fatigue using the FACIT-Fatigue Scale, quality of life through questionnaires, and blood tests to monitor drug levels and immune response. The main outcome is the proportion of participants who become independent of RBC transfusions for at least 12 consecutive weeks with improved hemoglobin. Safety and overall health will be closely monitored, including tracking any progression to acute myeloid leukemia or death. The total participation duration may last up to several years to evaluate long-term effects.

Researchers are evaluating the efficacy and safety of luspatercept combined with best supportive care (BSC) compared to placebo plus BSC for treating anemia in adults with alpha-thalassemia hemoglobin H (HbH) disease. The study also aims to assess the safety and drug levels of luspatercept in adolescent participants. This Phase 2 trial is sponsored by Bristol-Myers Squibb and focuses on improving anemia management in this specific patient group. Participants are divided into groups based on transfusion dependence and age. Adult transfusion-dependent and non-transfusion-dependent participants receive either luspatercept plus BSC or placebo plus BSC. Adolescent participants aged 12 to under 18 years are assessed for safety and pharmacokinetics of luspatercept. Treatments involve specified doses given on designated days, with monitoring across several weeks. The study includes a randomized, quadruple-masked design to compare outcomes effectively. During the study, participants undergo regular assessments including blood tests to measure hemoglobin levels, red blood cell transfusion requirements, and adverse events. Researchers also monitor pharmacokinetics and immunogenicity over extended periods up to several years. Patient-reported outcomes, quality of life, physical function tests, and biomarkers related to anemia and iron homeostasis are evaluated to understand treatment impact. The total participation may last up to 8.5 years, ensuring comprehensive safety and efficacy data collection.

This research aims to evaluate the safety, effectiveness, and how the body processes ferumoxytol for treating iron deficiency anemia (IDA) in children aged 2 to under 18 years. The study includes male and female pediatric subjects with IDA or those considered at risk of developing IDA by their clinician, regardless of cause, except for those with chronic kidney disease (CKD), who are studied separately. Participants will be randomly assigned in a 2:1 ratio to receive either ferumoxytol or iron sucrose. Ferumoxytol is given as two intravenous doses of 7 mg iron per kg, with a maximum of 510 mg per dose; the first dose is on Day 1 and the second dose is 2 to 8 days later. Iron sucrose is given as five intravenous doses of 4 mg iron per kg, with a maximum of 200 mg per dose; the first dose is on Day 1 and the remaining doses are given at least once per week and up to three times per week. Participants are monitored for one hour after each infusion. Throughout the study, which lasts up to 5 weeks, researchers will assess hemoglobin levels, check for side effects or adverse events, and perform other safety tests. The main outcome measured is the change in hemoglobin from the start to Week 5. Additional safety assessments include tracking any new or special adverse events up to 49 days after treatment begins.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of ferumoxytol compared to iron sucrose in children with chronic kidney disease (CKD) who have iron deficiency anemia (IDA) or are at risk of developing it. The study focuses on pediatric patients aged 2 to under 18 years and aims to better understand ferumoxytol's profile in this group. This Phase 3, randomized, open-label study involves multiple centers and approximately 125 participants. Participants will be randomly assigned in a 2:1 ratio to receive either ferumoxytol or iron sucrose. Those in the ferumoxytol group will get two intravenous infusions of 7.0 mg Fe/kg (up to 510 mg per dose), the first on Day 1 and the second 2 to 8 days later. Those receiving iron sucrose will have dosing based on dialysis status: hemodialysis-dependent patients receive 2 mg Fe/kg on consecutive dialysis sessions for 10 doses, and non-hemodialysis-dependent or peritoneal dialysis-dependent patients receive 4 mg Fe/kg up to three times per week for 5 doses, with total maximum doses capped at 1000 mg. The study lasts up to 7 weeks, including a 2-week screening period and a 5-week treatment period. Researchers will monitor hemoglobin changes, adverse events, and special safety concerns during 49 days of follow-up. Assessments include blood tests to measure hemoglobin and iron levels, safety evaluations, and pharmacokinetic and pharmacodynamic analyses. This helps determine how participants respond and tolerate the treatments over time.

Researchers are evaluating APG-5918, an oral drug, to study its safety, how it moves within the body, and its early effects in healthy adults and patients with anemia. This Phase 1 trial aims to find out if APG-5918 is safe and tolerable and to explore dosing levels that might be effective for anemia treatment. The study includes healthy volunteers and patients with anemia, including those with beta-thalassemia and related conditions. The trial has two parts. Part A randomly assigns healthy volunteers to receive a single dose of APG-5918 or a placebo in a double-blind manner, with dose levels increasing across up to seven groups. Part B involves an open-label, multi-dose approach where anemic patients receive daily APG-5918 for 84 days or until treatment end. The study monitors safety, tolerability, drug levels in the blood, and preliminary effects on hemoglobin. Participants will undergo assessments including blood tests to measure drug concentration and hemoglobin levels, and monitoring for any adverse events up to 7 days in Part A and 84 days or until treatment end in Part B. The trial includes physical exams, lab tests, and ECGs to ensure safety. Total participation duration varies, with regular visits to assess how well the drug is tolerated and its early effects on anemia.