Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE July 20, 2019
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
Hemoglobin level [ Time Frame: 24 weeks ]
Change in Hb levels from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04012957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Hemoglobin Response [ Time Frame: 24 weeks ]
    No. of subjects with Hb response
  • Hemoglobin target range [ Time Frame: 24 weeks ]
    Time to achieve target range Hb level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Desidustat in the Treatment of Anemia in CKD
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease Stage 3
  • Anemia
  • Chronic Kidney Disease Stage 4
  • Chronic Kidney Disease Stage 5
Intervention  ICMJE
  • Drug: Desidustat Oral Tablet
    Desidustat tablet
  • Drug: Darbepoetin Alfa
    Darbepoetin injection
Study Arms  ICMJE
  • Experimental: Darbepoetin Alfa Injection
    Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
    Intervention: Drug: Darbepoetin Alfa
  • Active Comparator: Desidustat oral tablet
    Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
    Intervention: Drug: Desidustat Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
588
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 %.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: DrDeven Parmar, MD +912717665555 ext 451 deven.parmar@zydusdiscovery.ae
Contact: Dr Kevin Kansagra, MD +912717665555 ext 279 Kekevinkumarkansagra@zyduscadila.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012957
Other Study ID Numbers  ICMJE DESI.18.001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cadila Healthcare Limited
Study Sponsor  ICMJE Cadila Healthcare Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: DrDeven Parmar, MD Cadila Healthcare Limited
PRS Account Cadila Healthcare Limited
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP