A Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD) who are not on Dialysis

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Current clinical diagnosis of anemia due to CKD with baseline hemoglobin concentrations between 7.0-10.0 g/dL (both inclusive) before the enrollment.
2. Ability to understand and give informed consent for participation.
3. Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis) defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
4. Male or female, 18 to 80 years of age.
5. Body weight > 40 kg.
6. Subjects not on dialysis and not expected to start dialysis during the study period.
7. Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
8. Estimated GFR >10 mL/min/1.73 m2.
9. Serum ferritin >100 ng/mL and/or TSAT >20%.
10. No iron, folate or Vitamin B12 deficiency.
11. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.

Exclusion Criteria

1.Prior chronic hemodialysis or chronic peritoneal dialysis treatment.

2.Intravenous iron within 14 days prior to enrollment.

3.Prior exposure of rhEPO analogues less than 04 weeks.

4.Red blood cell transfusion within 8 weeks prior to enrollment.

5.History of previous or concurrent cancer.

6.Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.

7.Active infection prior to enrollment.

8.History of renal transplant.

9.Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
10.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.

11.History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.

12.Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.

13.History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

14.History of severe allergic or hypersensitivity to investigational products and its excipients.

15.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 patient safety.

16.Pregnant and breastfeeding women.

17.Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.

18.Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.

19.Presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the Investigator's opinion, could compromise the patient's safety.

20.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).

21.History of difficulty with donating blood.

22.History or presence of any clinically significant ECG abnormalities during screening.

23.Participants who have participated in any drug research study other than the present trial within past 3 months.

24.Participants who have donated one unit (350 ml) of blood in the past 3 months or history of whole blood transfusion in last 120 days prior to enrollment.

25.History of chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease, Systemic Lupus Erythematosus [SLE]).

26.In case of DM patients, glycosylated haemoglobin (HbA1c) >9 %.

27.In case of hypertensive patients, systolic and diastolic BP is > 160 and 100 mm of Hg respectively or uncontrolled blood pressure.

28.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 adequa

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in haemoglobin [(Duration: Week 24)]<br>

Secondary Outcome Measures

Name	Time	Method
1. Hb responders <br>(Defined as achievement of target level of 10-12 g/dL and post-treatment increase of 1 g/dL or more in Hb by Week 24)<br><br>2. Time to achieve target range Hb level <br>(Defined as Hb level of 10-12 g/dL)<br><br>3. Percentage of time spent in target Hb range <br><br>4. Serum hepcidin level<br><br>5. Serum Potassium (K+) <br><br>6. Quality of life by SF-36<br>(Short Form (36) Health Survey)<br>7. Need for rescue therapy during study treatment <br><br>8. Vascular endothelial growth factor (VEGF) 9 levels <br><br>9.Lipid profile and lipoproteins [24 Week]<br>