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Desidustat in the Treatment of Anemia in CKD on Dialysis Patients (DREAM-D)

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: NCT04215120
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

Brief Summary:
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 5 on Dialysis Drug: Desidustat Oral Tablet Drug: Epoetin Alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Epoetin Alfa Injection for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) on Dialysis (DREAM-D)
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : August 28, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Epoetin Injection
Randomly assigned to receive Epoetin in a 1:1 ratio for 24 weeks.
Drug: Epoetin Alfa
Epoetin Injection




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

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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. Ability to understand and give informed consent for participation. 2. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).

3.

  1. Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR
  2. Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).

    4. Patients on hemodialysis (≥2 times in a week) for at least 12 weeks prior to screening visit and have access consisting of an arteriovenous fistula, AV graft, or catheter (permanent/temporary).

    5. Patients with no planned change in dialysis modality and with no planned renal transplant during study period.

    6. Left ventricular ejection fraction ≥40% by echocardiogram prior to randomization.

    7. No iron, folate or Vitamin B12 deficiency.

    8. 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. Red blood cell transfusion within 8 weeks prior to participating in the study.
    2. History of previous or concurrent cancer.
    3. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
    4. Active infection at initiation of study.
    5. History of renal transplant.
    6. Uncontrolled hypertension (defined as SBP >180 mmHg or DBP >100 mmHg) at screening visit (before dialysis).
    7. Patient on high rhEPO dose at screening visit. [High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous].
    8. 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.
    9. Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
    10. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
    11. 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.
    12. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
    13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Desidustat or Epoetin alfa or to any erythropoieisis-stimulating agent.
    14. Pregnant and breastfeeding women.
    15. Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
    16. Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
    17. Presence of other clinically significant 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.
    18. 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).
    19. History of difficulty with donating blood.
    20. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening.
    21. Participants who have participated in any drug research study other than the present trial within past 3 months.
    22. 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 entry in the study.
    23. Existing clinically active chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease)
    24. In case of DM patients, HbA1c >9%.
    25. Female volunteers with following criteria will not be recruited:

      • History of pregnancy or lactation in the past 3 months
      • Fertile female volunteers not protected against pregnancy by adequate long- term anti-fertility measures
      • History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
      • Positive urine pregnancy test at Visit 2
      • Positive serum β-hCG level at the screening visit
    26. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or history of myocardial infarction prior to first dose with study drug.

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): NCT04215120


Contacts
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Contact: Dr Deven Parmar, MD +912717665555 ext 451 deven.parmar@zyduscadila.com
Contact: Dr Kevin kansagra, MD +912717665555 ext 279 kevinkumar.kansagra@zyduscadila.com

Locations
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India
Karnavati Hospital Pvt.Ltd Not yet recruiting
Ahmedabad, Gujarat, India, 380006
Contact: Dr Javed M Vakil    9824919119    jmvakil@hotmail.com   
Shalby Hospital, Recruiting
Ahmedabad, Gujarat, India, 380015
Contact: Dr Kamal Goplani    9512016866    kamalgoplani@gmail.com   
DHS Multispecialty Hospital Not yet recruiting
Ahmedabad, Gujarat, India, 380054
Contact: Dr Siddharth Mavani    9825317953    msiddh@yahoo.co.in   
Chopda Medicare & Research Centre Pvt. Ltd Not yet recruiting
Nashik, Maharashtra, India, 422005
Contact: Dr Kailas Shewale    9960500350    kailashshewale@gmail.com   
Aditya Birla Memorial Hospital Not yet recruiting
Pune, Maharashtra, India, 411033
Contact: Dr Tarun Jaloka    9370691221    tjeloka@yahoo.com   
Eternal Hospital Not yet recruiting
Jaipur, Rajasthan, India, 302017
Contact: Dr Ashok Kumar Sharma    9829065210    draksharma_50@yahoo.com   
Star Hospital Not yet recruiting
Hyderabad, Telangana, India, 500034
Contact: Dr Rajasekara M    9391059322    rajasekarac@gmail.com   
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
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Study Director: Dr Deven Parmar, MD Cadila Healthcare Limited
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Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT04215120    
Other Study ID Numbers: DESI.19.001.01
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics