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Desidustat in the Treatment of Anemia in CKD (DREAM-ND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04012957
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 3 Anemia Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5 Drug: Desidustat Oral Tablet Drug: Darbepoetin Alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Darbepoetin Alfa Injection
Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
Drug: Darbepoetin Alfa
Darbepoetin injection

Active Comparator: Desidustat oral tablet
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
Drug: Desidustat Oral Tablet
Desidustat tablet




Primary Outcome Measures :
  1. Hemoglobin level [ Time Frame: 24 weeks ]
    Change in Hb levels from baseline


Secondary Outcome Measures :
  1. Hemoglobin Response [ Time Frame: 24 weeks ]
    No. of subjects with Hb response

  2. Hemoglobin target range [ Time Frame: 24 weeks ]
    Time to achieve target range Hb level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 %.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012957


Contacts
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Contact: DrDeven Parmar, MD +912717665555 ext 451 deven.parmar@zydusdiscovery.ae
Contact: Dr Kevin Kansagra, MD +912717665555 ext 279 Kekevinkumarkansagra@zyduscadila.com

Locations
Show Show 32 study locations
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
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Study Director: DrDeven Parmar, MD Cadila Healthcare Limited

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Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT04012957    
Other Study ID Numbers: DESI.18.001
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cadila Healthcare Limited:
DREAM-ND
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics