Desidustat in the Treatment of Anemia in CKD

Anemia Clinical Trial

— DREAM-ND  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012957
• Other study ID #: DESI.18.001
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2019
• Est. completion date: August 25, 2021

Study information

• Verified date: July 2020
• Source: Cadila Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: August 25, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 %.

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease Stage 3
• Chronic Kidney Disease Stage 4
• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Desidustat Oral Tablet
Desidustat tablet
• Darbepoetin Alfa
Darbepoetin injection

Locations

Country	Name	City	State
India	Thakershey Charitable trust Hospital	Ahmadabad	Gujarat
India	GSC Medical College and Research Centre	Ahmedabad	Gujarat
India	HCG Hospital	Ahmedabad	Gujarat
India	Sangini Hospital	Ahmedabad	Gujarat
India	Mahatma Gandhi Mission Medical College & Hospital	Aurangabad	Maharashtra
India	Sapthagiri Institute of Medical Sciences	Bangalore	Karnataka
India	Apollo Hospital	Bhubaneswar	Orissa
India	Sardar Patel Medical College	Bikaner	Rajasthan
India	Shri Mahant Indiresh Hospital	Dehradun	Uttaranchal
India	Fortis Hospital	Delhi	New Delhi
India	Apollo Hospital	Hyderabad	Telangana
India	Nizams Institute of Medical Sciences	Hyderabad	Telangana
India	Nizams Institute of Medical Sciences	Hyderabad	Telangana
India	Osmania General Hospital	Hyderabad	Telangana
India	Eternal Hospital	Jaipur	Rajasthan
India	Rukmani Birla Hospital	Jaipur	Rajasthan
India	Sawai Man Singh (SMS) Medical College and Hospital	Jaipur	Rajasthan
India	Amrita Institute of Medical Science	Kochi	Kerala
India	Medica Superspecialty Hospital	Kolkata	West Bangal
India	Peerless Hospital	Kolkata	WEST Bengal
India	Government Medical College	Kozhikode	Kerala
India	Kasturba Medical College	Mangalore	Karnataka
India	Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd)	Nashik	Maharashtra
India	Max Super Specialty Hospital	New Delhi	Delhi
India	Noble Hospital	Pune	Maharashtra
India	BAPS Pramukh Swami Hospital	Surat	Gujarat
India	Asian Institute Of Medical Sciences (AIMS) Hospital	Thane	Maharashtra
India	Bhaktivedanta Hospital and Research Institute	Thane	Maharashtra
India	Dhiraj General Hospital	Vadodara	Gujarat
India	Sterling Hospital	Vadodara	Gujarat
India	Heritage Hospitals Limited	Varanasi	Uttar Pradesh
India	Sunrise Hospital	Vijayawada	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Healthcare Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level	Change in Hb levels from baseline	24 weeks
Secondary	Hemoglobin Response	No. of subjects with Hb response	24 weeks
Secondary	Hemoglobin target range	Time to achieve target range Hb level	24 weeks