Desidustat in the Treatment of Anemia in CKD
DREAM-ND
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
1 other identifier
interventional
588
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
July 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2021
CompletedNovember 24, 2021
July 1, 2020
2.1 years
June 7, 2019
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin level
Change in Hb levels from baseline
24 weeks
Secondary Outcomes (2)
Hemoglobin Response
24 weeks
Hemoglobin target range
24 weeks
Study Arms (2)
Darbepoetin Alfa Injection
EXPERIMENTALRandomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
Desidustat oral tablet
ACTIVE COMPARATORRandomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
- Ability to understand and give informed consent for participation.
- 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.
- Male or female, 18 to 80 years of age.
- Body weight \> 40 kg.
- Subjects not on dialysis and not expected to start dialysis during the study period.
- Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
- Estimated GFR ≥10 mL/min/1.73 m2.
- Serum ferritin ≥100 ng/mL and/or Transferrin Saturation \>20%.
- No iron, folate or Vitamin B12 deficiency.
- Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.
You may not qualify if:
- Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- Intravenous iron within 14 days prior to enrollment.
- Prior exposure of rhEPO analogues less than 04 weeks.
- Red blood cell transfusion within 8 weeks prior to enrollment.
- History of previous or concurrent cancer.
- Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
- Active infection prior to enrollment.
- History of renal transplant.
- 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.
- 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.
- History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
- 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.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- History of severe allergic or hypersensitivity to investigational products and its excipients.
- 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Sunrise Hospital
Vijayawada, Andhra Pradesh, 520002, India
HCG Hospital
Ahmedabad, Gujarat, 380006, India
Sangini Hospital
Ahmedabad, Gujarat, 380015, India
GSC Medical College and Research Centre
Ahmedabad, Gujarat, 380025, India
Thakershey Charitable trust Hospital
Ahmedabad, Gujarat, India
BAPS Pramukh Swami Hospital
Surat, Gujarat, 395009, India
Sterling Hospital
Vadodara, Gujarat, 390007, India
Dhiraj General Hospital
Vadodara, Gujarat, 391760, India
Sapthagiri Institute of Medical Sciences
Bangalore, Karnataka, 560090, India
Kasturba Medical College
Mangalore, Karnataka, 575001, India
Amrita Institute of Medical Science
Kochi, Kerala, 682041, India
Government Medical College
Kozhikode, Kerala, 673008, India
Mahatma Gandhi Mission Medical College & Hospital
Aurangabad, Maharashtra, 431003, India
Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd)
Nashik, Maharashtra, 422002, India
Noble Hospital
Pune, Maharashtra, 411013, India
Bhaktivedanta Hospital and Research Institute
Thane, Maharashtra, 401107, India
Asian Institute Of Medical Sciences (AIMS) Hospital
Thane, Maharashtra, 421203, India
Max Super Specialty Hospital
New Delhi, National Capital Territory of Delhi, 110017, India
Fortis Hospital
Delhi, New Delhi, 110070, India
Apollo Hospital
Bhubaneswar, Odisha, 751005, India
Sardar Patel Medical College
Bikaner, Rajasthan, 334003, India
Sawai Man Singh (SMS) Medical College and Hospital
Jaipur, Rajasthan, 302004, India
Eternal Hospital
Jaipur, Rajasthan, 302017, India
Rukmani Birla Hospital
Jaipur, Rajasthan, 302018, India
Osmania General Hospital
Hyderabad, Telangana, 500012, India
Apollo Hospital
Hyderabad, Telangana, 500058, India
Nizams Institute of Medical Sciences
Hyderabad, Telangana, 500082, India
Nizams Institute of Medical Sciences
Hyderabad, Telangana, 524001, India
Heritage Hospitals Limited
Varanasi, Uttar Pradesh, 221311, India
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, 248001, India
Medica Superspecialty Hospital
Kolkata, West Bangal, 700099, India
Peerless Hospital
Kolkata, West Bengal, 700094, India
Related Publications (1)
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.
PMID: 36005278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
DrDeven Parmar, MD
Zydus Lifesciences Limited
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2019
First Posted
July 9, 2019
Study Start
July 20, 2019
Primary Completion
August 25, 2021
Study Completion
August 25, 2021
Last Updated
November 24, 2021
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share