Phase
Condition
Chronic Renal Anemia
Anemia
Treatment
Desidustat
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, ≥ 18 years of age.
Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrationsmust be 7.0-11.0 g/dL (both inclusive) before the enrolment.
Ability to understand and give informed consent for participation.
No significant folate or Vitamin B12 deficiency.
Females of childbearing potential, must agree to use one of the approvedcontraception methods, from screening until End-of-study visit.
For Subjects dependent on hemodialysis:
Must be receiving haemodialysis session ≥2 times in a week for at least 12weeks prior to screening visit and have access consisting of an arteriovenousfistula, AV graft, or catheter (permanent/temporary).
Subjects will be considered not treated with erythropoietin analogue (Epoetinand 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 Subjectswho are on ESA therapy must be on stable dose for 4 weeks prior to enrolment (≤30% of dose change).
Exclusion
Exclusion Criteria:
Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.
Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior toenrolment.
In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) > 9 %.
In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is >160and 100 mm of Hg respectively or uncontrolled blood pressure.
History of previous or concurrent cancer or renal transplant or severe allergic orhypersensitivity to investigational products and its excipients or chronicinflammatory disease (RA, Celiac disease, UC, Crohn's disease, Systemic LupusErythematosus [SLE]).
Serologic status reflecting active Hepatits B or C infection or HumanImmunodeficiency virus (HIV) infection.
History of uncontrolled autoimmune haemolytic anemia, idiopathic thrombocytopenicpurpura (ITP) or thalassemia/bleeding disorders or clinical conditions (e.g.gastrointestinal [GI] bleeding or constitutional disorders) that may increase riskof life-threatening bleeding./ requires or is receiving anticoagulation withwarfarin or equivalent vitamin K antagonists or other medications within 28 days ofthe first dose of study drug that in the investigator's opinion, could compromisesubject safety.
Major surgery within 90 days and minor surgery within 30 days prior to the enrolmentof the subject.
Unable to swallow tablets or disease significantly affecting gastrointestinalfunction and/or inhibiting small intestine absorption such as; mal-absorptionsyndrome, resection of the small bowel or poorly controlled inflammatory boweldisease affecting the small intestine.
History of myocardial infarction or stroke or intracranial haemorrhage within 6months prior to enrolment.
Currently active clinically significant cardiovascular disease such as uncontrolledarrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined bythe NYHA (New York Heart Association) classification.
Current life-threatening illness, medical condition, systemic disorders (e.g.,respiratory, gastrointestinal, endocrine, immunological, dermatological,neurological, psychiatric disease or any other body system involvement) orlaboratory abnormalities which, in the Investigator's opinion, could compromise thesubject's safety.
History of significant alcoholism or drug abuse within the past 1 year. History orpresence of significant smoking (more than 10 cigarettes per day) or consumption oftobacco/nicotine products (more than 10 times per day).
History of difficulty with donating blood.
History or presence of any clinically significant ECG abnormalities duringscreening.
Participants who have participated in any drug research study other than the presenttrial within past 3 months.
Female volunteers with following criteria will not be eligible:
History of pregnancy or lactation in the past 3 months.
Fertile female volunteers not protected against pregnancy by adequate long-termanti-fertility measures.
History of less than 1 year of menopause and not using adequate long-termantifertility measures.
Oral hormone replacement therapy.
Positive serum β-hCG level at the screening visit.
Pregnant and breastfeeding women.
Abnormal baseline laboratory investigations as follows:
WBC count ≤3 x 103/μL.
Platelets count ≤100 x 103/μL.
Bilirubin ≥2.0 mg/dL.
ALT and/or AST ≥2.5 times of the ULN.
Study Design
Study Description
Connect with a study center
Indira Gandhi Institute of Medical Sciences
Sheikhpura, Bihar 800014
IndiaActive - Recruiting
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