A post marketingsurveillance to evaluate the safety of Desidustat for thetreatment of anemia in subjects with chronic kidney disease(CKD).
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2022/12/047956
- Lead Sponsor
- Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female, = 18 years of age.
2.Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g/dL (both inclusive) before the enrolment.
3.Ability to understand and give informed consent for participation.
4.No significant folate or Vitamin B12 deficiency.
5.Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until End-of-study visit.
6.For Subjects dependent on hemodialysis:
a. 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/temporary).
b. 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).
1.Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.
2.Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior to
enrolment.
3. In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) > 9 %.
4. In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is greater than 160 and 100 mm of Hg respectively or uncontrolled blood pressure.
5. 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]).
6.Serologic status reflecting active Hepatits B or C infection or Human
Immunodeficiency virus (HIV) infection.
7.History of uncontrolled autoimmune haemolytic anemia, idiopathicthrombocytopenic purpura (ITP) or thalassemia/bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding./ 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.
8.Major surgery within 90 days and minor surgery within 30 days prior to the enrolment of the subject.
9.Unable to swallow tablets or disease significantly affecting gastrointestinal function
and/or inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
10.History of myocardial infarction or stroke or intracranial haemorrhage within 6 months prior to enrolment.
11.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.
12.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/nicotine products (more than 10 times per day).
13.History of difficulty with donating blood.
14.History or presence of any clinically significant ECG abnormalities during screening.
15.Participants who have participated in any drug research study other than the present
trial within past 3 months.
16.Female volunteers with following criteria will not be eligible:
a. History of pregnancy or lactation in the past 3 months.
b. Fertile female volunteers not protected against pregnancy by adequate long-term
anti-fertility measures.
c. History of less than 1 year of menopause and not using adequate long-term antifertility
measures.
d. Oral hormone replacement therapy.
e. Positive serum ß-hCG level at the screening visit.
f. Pregnant and breastfeeding women.
18. Abnormal baseline laboratory investigations as follows:
a. WBC count =3 x 103/µL.
b. Platelets count =100 x 103/µL.
c. Bilirubin =2.0 mg/dL.
d. ALT and/or AST =2.5 times of the ULN.
18.current life-threatening illness, medical condition
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Subjects with treatment emergent adverse <br/ ><br>events and serious adverse eventTimepoint: Baseline to week 52(EOT)
- Secondary Outcome Measures
Name Time Method Evaluation safety laboratory parametersTimepoint: Baseline to week 52(EOT);Mean change in hemoglobin levelTimepoint: Baseline to week 52(EOT);Mean change in Lipid profile including Small dense <br/ ><br>LDLTimepoint: Baseline to week 52(EOT);Mean change in serum HepcidinTimepoint: Baseline to week 52(EOT);Mean change in VEGFTimepoint: Baseline to week 52(EOT)