Desidustat in the Treatment of Anemia in CKD on Dialysis Patients

NCT04215120 | Completed Phase 3

• 1 other identifier: DESI.19.001.01
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 7

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)

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

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)

Desidustat oral tablet

ACTIVE COMPARATOR

Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.

Drug: Desidustat Oral Tablet

Epoetin Injection

EXPERIMENTAL

Randomly assigned to receive Epoetin in a 1:1 ratio for 24 weeks.

Drug: Epoetin Alfa

Interventions

Desidustat Oral Tablet DRUG

Desidustat tablet

Desidustat oral tablet

Epoetin Alfa DRUG

Epoetin Injection

Epoetin Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ability to understand and give informed consent for participation. 2. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
• 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
• Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).
• \. 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).
• \. Patients with no planned change in dialysis modality and with no planned renal transplant during study period.
• \. Left ventricular ejection fraction ≥40% by echocardiogram prior to randomization.
• \. 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:

• Red blood cell transfusion within 8 weeks prior to participating in the study.
• History of previous or concurrent cancer.
• Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
• Active infection at initiation of study.
• History of renal transplant.
• Uncontrolled hypertension (defined as SBP \>180 mmHg or DBP \>100 mmHg) at screening visit (before dialysis).
• Patient on high rhEPO dose at screening visit. \[High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous\].
• 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; malabsorption 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 allergic reactions attributed to compounds of similar chemical or biologic composition to Desidustat or Epoetin alfa or to any erythropoieisis-stimulating agent.
• Pregnant and breastfeeding women.
• Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (7)

Karnavati Hospital Pvt.Ltd

Ahmedabad, Gujarat, 380006, India

Location

Shalby Hospital,

Ahmedabad, Gujarat, 380015, India

Location

DHS Multispecialty Hospital

Ahmedabad, Gujarat, 380054, India

Location

Chopda Medicare & Research Centre Pvt. Ltd

Nashik, Maharashtra, 422005, India

Location

Aditya Birla Memorial Hospital

Pune, Maharashtra, 411033, India

Location

Eternal Hospital

Jaipur, Rajasthan, 302017, India

Location

Star Hospital

Hyderabad, Telangana, 500034, India

Location

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: 36005278 DERIVED

MeSH Terms

Interventions

desidustat; Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Dr Deven Parmar, MD

  Zydus Lifesciences Limited

  STUDY DIRECTOR

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: December 22, 2019
• First Posted: January 2, 2020
• Study Start: January 4, 2020
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (7)