Clinical trial NCT04012957: Desidustat in the Treatment of Anemia in CKD
Official title: A Phase 3, Multicenter, Multi-country, Open-label, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease Stage 3
Anemia
Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 5
Keywords: DREAM-ND
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.


Eligibility criteria: Inclusion Criteria:

1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 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 Transferrin Saturation \>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 Diabetes mellitus patients, glycosylated haemoglobin (HbA1c) \>9 %.

Primary outcomes:
measure: Hemoglobin level
timeFrame: 24 weeks
Secondary outcomes:
measure: Hemoglobin Response
timeFrame: 24 weeks
measure: Hemoglobin target range
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Vijayawada
country: India
facility: Sunrise Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Max Super Specialty Hospital
state: Delhi
city: Ahmadabad
country: India
facility: Thakershey Charitable trust Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: HCG Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Sangini Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: GSC Medical College and Research Centre
state: Gujarat
city: Sūrat
country: India
facility: BAPS Pramukh Swami Hospital
state: Gujarat
city: Vadodara
country: India
facility: Sterling Hospital
state: Gujarat
city: Vadodara
country: India
facility: Dhiraj General Hospital
state: Gujarat
city: Bangalore
country: India
facility: Sapthagiri Institute of Medical Sciences
state: Karnataka
city: Mangalore
country: India
facility: Kasturba Medical College
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Science
state: Kerala
city: Kozhikode
country: India
facility: Government Medical College
state: Kerala
city: Aurangabad
country: India
facility: Mahatma Gandhi Mission Medical College & Hospital
state: Maharashtra
city: Nashik
country: India
facility: Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd)
state: Maharashtra
city: Pune
country: India
facility: Noble Hospital
state: Maharashtra
city: Thāne
country: India
facility: Bhaktivedanta Hospital and Research Institute
state: Maharashtra
city: Thāne
country: India
facility: Asian Institute Of Medical Sciences (AIMS) Hospital
state: Maharashtra
city: Delhi
country: India
facility: Fortis Hospital
state: New Delhi
city: Bhubaneswar
country: India
facility: Apollo Hospital
state: Orissa
city: Bīkaner
country: India
facility: Sardar Patel Medical College
state: Rajasthan
city: Jaipur
country: India
facility: Sawai Man Singh (SMS) Medical College and Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Eternal Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Rukmani Birla Hospital
state: Rajasthan
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Hyderabad
country: India
facility: Apollo Hospital
state: Telangana
city: Hyderabad
country: India
facility: Nizams Institute of Medical Sciences
state: Telangana
city: Hyderabad
country: India
facility: Nizams Institute of Medical Sciences
state: Telangana
city: Varanasi
country: India
facility: Heritage Hospitals Limited
state: Uttar Pradesh
city: Dehradun
country: India
facility: Shri Mahant Indiresh Hospital
state: Uttaranchal
city: Kolkata
country: India
facility: Medica Superspecialty Hospital
state: West Bangal
city: Kolkata
country: India
facility: Peerless Hospital
state: WEST Bengal
Study officials:
affiliation: Zydus Lifesciences Limited
name: DrDeven Parmar, MD
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.