[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zydus Lifesciences Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100478852","phase-4-a-post-marketing-surveillance-to-evaluate-the-safety-of-desidustat-for-the-treatment-of-anemia-in-subjects-with-chronic-kidney-disease-ckdreal-world-evidence-study-100478852",false,"NCT05515367","A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)","A Phase 4,52 Week, Single Arm,Multicentre Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).","Inclusion Criteria:\n\n1. Male or female, ≥ 18 years of age.\n2. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g\u002FdL (both inclusive) before the enrolment.\n3. Ability to understand and give informed consent for participation.\n4. No significant folate or Vitamin B12 deficiency.\n5. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until End-of-study visit.\n6. For Subjects dependent on hemodialysis:\n\n   1. Must be receiving haemodialysis session ≥2 times in a week for at least 12 weeks prior to screening visit and have access consisting of an arteriovenous fistula, AV graft, or catheter (permanent\u002Ftemporary).\n   2. Subjects will be considered not treated with erythropoietin analogue (Epoetin and Darbepoetin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR Subjects who are on ESA therapy must be on stable dose for 4 weeks prior to enrolment (≤30% of dose change).\n\nExclusion Criteria:\n\n1. Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.\n2. Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior to enrolment.\n3. In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) \\> 9 %.\n4. In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is \\>160 and 100 mm of Hg respectively or uncontrolled blood pressure.\n5. History of previous or concurrent cancer or renal transplant or severe allergic or hypersensitivity to investigational products and its excipients or chronic inflammatory disease (RA, Celiac disease, UC, Crohn's disease, Systemic Lupus Erythematosus \\[SLE\\]).\n6. Serologic status reflecting active Hepatits B or C infection or Human Immunodeficiency virus (HIV) infection.\n7. History of uncontrolled autoimmune haemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia\u002Fbleeding disorders or clinical conditions (e.g. gastrointestinal \\[GI\\] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.\u002F requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists or other medications within 28 days of the first dose of study drug that in the investigator's opinion, could compromise subject safety.\n8. Major surgery within 90 days and minor surgery within 30 days prior to the enrolment of the subject.\n9. Unable to swallow tablets or disease significantly affecting gastrointestinal function and\u002For inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.\n10. History of myocardial infarction or stroke or intracranial haemorrhage within 6 months prior to enrolment.\n11. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the NYHA (New York Heart Association) classification.\n12. Current life-threatening illness, medical condition, systemic disorders (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) or laboratory abnormalities which, in the Investigator's opinion, could compromise the subject's safety.\n13. History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco\u002Fnicotine products (more than 10 times per day).\n14. History of difficulty with donating blood.\n15. History or presence of any clinically significant ECG abnormalities during screening.\n16. Participants who have participated in any drug research study other than the present trial within past 3 months.\n17. Female volunteers with following criteria will not be eligible:\n\n    1. History of pregnancy or lactation in the past 3 months.\n    2. Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures.\n    3. History of less than 1 year of menopause and not using adequate long-term antifertility measures.\n    4. Oral hormone replacement therapy.\n    5. Positive serum β-hCG level at the screening visit.\n    6. Pregnant and breastfeeding women.\n18. Abnormal baseline laboratory investigations as follows:\n\n    1. WBC count ≤3 x 103\u002FμL.\n    2. Platelets count ≤100 x 103\u002FμL.\n    3. Bilirubin ≥2.0 mg\u002FdL.\n    4. ALT and\u002For AST ≥2.5 times of the ULN.","ALL","18 Years","85 Years",{"count":20,"type":21},1004,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","A Phase 4, 52 week, single arm, multicentre post marketing surveillance to evaluate the safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease (CKD)",[27,28],"Chronic Kidney Diseases","Anemia of Chronic Kidney Disease",[30],"Real World Evidence Study","RECRUITING","2025-01-21",{"date":34,"type":35},"2025-01-22","ACTUAL",{"date":37,"type":35},"2023-04-20",{"date":39,"type":21},"2025-11-30",{"name":41,"class":42},"Zydus Lifesciences Limited","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100509315","phase-1-a-study-to-determine-safety-tolerability-and-pharmacokinetics-of-different-orally-administered-regimens-of-the-combination-zy19489-ferroquine-in-adult-asymptomatic-plasmodium-falciparum-carriers-100509315","NCT05911828","A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers","Phase Ib, Single-center, Randomized, Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers","ZYFER-1","Inclusion Criteria:\n\n\\- 1. Male and female (non-pregnant, non-lactating) subjects aged between 18 and 55 years old 2. Participant's body weight ≥ 45 kg 3. Evidence of asymptomatic infection with Plasmodium falciparum mono-infection on microscopy with parasite density between 20\u002FµL and 5000\u002FµL.\n\n4\\. Participants should agree to not donate blood from enrolment in the study until end of the follow-up period 5. Ability to swallow oral medication 6. Evidence of written informed consent personally signed and dated by the participant.\n\nSigned informed consent obtained prior to participation in the study. In case of participant unable to read and write or otherwise incapable of signing an informed consent, an impartial witnessed consent shall be obtained. Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* 1\\. Mixed Plasmodium infection as judged by microscopy. 2. Presence of clinically significant infectious disease or fever (e.g. Body temperature ≥38°C or 100.4°F) within the 14 days prior to enrollment.\n\n  3\\. History of alcohol or drug abuse or positive urine alcohol test or urine drug test.\n\n  4\\. Consumption of beverages or food containing xanthine bases including chocolate, coffee etc. from 48 hours prior to enrollment.\n\n  5\\. Known allergy to the study drugs and to the rescue medications (artemisinin derivatives, lumefantrine) as well as their excipients.\n\n  6\\. History of having received any antimalarial treatment (alone or in combination) during the following periods before screening:\n  1. Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks prior to screening.\n  2. Amodiaquine, chloroquine within 4 weeks prior to screening.\n  3. Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine, lumefantrine or any other anti-malarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to screening.\n\n     7\\. Laboratory parameters outside normal range or with clinically relevant abnormalities as per investigator's judgment.\n\n     8\\. Electrolyte levels outside normal range 9. Hematology, clinical chemistry or urinalysis results at screening that were outside of clinically acceptable laboratory ranges and were considered clinically significant by the Investigator.\n\n     10\\. GFR\\\u003C60 ml\u002Fmin. 11. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance within 3 months of screening.\n\n     12\\. Participation in other clinical studies within 90 days before screening. 13. Pregnant or nursing (lactating) women. 14. Sexually active participants not willing to take effective contraception measures from enrolment until the last study visit: For female participants, combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner.\n\n     15\\. All male participants not willing to use either true abstinence, barrier method or with their sexual partner, the use of effective means of contraception from enrolment and until the last study visit.\n\n     16\\. Participant who the investigator considers at particular risk of receiving an anti-malarial or of participating in the study.","55 Years",{"count":54,"type":21},36,[56],"PHASE1","Malaria is caused by protozoan parasites of the genus Plasmodium and it is the most important parasitic disease in terms of mortality and morbidity. Estimates of 247 million malaria cases and 619.000 deaths worldwide were reported by WHO for the year 2021 (1). Plasmodium falciparum can lead to severe malaria and accounts for 90% of malaria deaths that mainly occur in children below the age of 5 years in Sub-Saharan Africa.\n\nA simplified treatment regimen, ideally a single-day cure (or at most 2-day dosing regimen), of uncomplicated malaria due to P. falciparum would be the magic in the antimalarial armamentarium. Improving treatment adherence is one of the key factors in reducing mortality and morbidity and also the transmission of malaria, and such a regimen would substantially increase adherence. To find a new non-artemisinin combination therapy with a shorter regimen, ideally, a single-dose cure, with low resistance potential would be the aim. The two compounds tested here are ZY19489, a triaminopyrimidine, and ferroquine (FQ), a next-generation 4-aminoquinoline. Both compounds show unique features in terms of long half-life, and activity against current drug-resistant strains.\n\nTherefore, the main goal of this clinical trial is to assess the safety of the ZY19489-FQ combination given as a 1- or 2-day dose regimen.",[59,60,61],"Uncomplicated Malaria","Asymptomatic Condition","Falciparum Malaria","2024-09-27",{"date":64,"type":35},"2024-10-01",{"date":66,"type":35},"2024-08-30",{"date":68,"type":21},"2025-05-30",{"name":41,"class":42},""]