A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

NCT05515367 | Recruiting Phase 4

• 1 other identifier: DESI.22.001
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 4, 52 week, single arm, multicentre post marketing surveillance to evaluate the safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease (CKD)

Conditions

Chronic Kidney Diseases; Anemia of Chronic Kidney Disease

Keywords

Real World Evidence Study

Outcome Measures

Primary Outcomes (2)

• To asses the Proportion of Subjects with treatment emergent adverse events.

  Baseline (week 0) to Week 52 (end of treatment)

• To asses the Proportion of Subjects with treatment emergent Serious adverse events.

  Baseline (week 0) to Week 52 (end of treatment)

Secondary Outcomes (4)

• Mean change in hemoglobin level

  Baseline (week 0) to Week 52 (end of treatment)

• Mean change in Lipid profile including Small dense LDL from baseline

  Baseline (week 0) to Week 52 (end of treatment)

• Mean change in VEGF

  Baseline (week 0) to Week 52 (end of treatment)

• Mean change in serum Hepcidin

  Baseline (week 0) to Week 52 (end of treatment)

Study Arms (1)

Desidustat oral tablet

EXPERIMENTAL

Oral administration of Desidustat from baseline (week 0) to Week 52

Drug: Desidustat

Interventions

Desidustat DRUG

Oral tablet

Desidustat oral tablet

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥ 18 years of age.
• Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g/dL (both inclusive) before the enrolment.
• Ability to understand and give informed consent for participation.
• No significant folate or Vitamin B12 deficiency.
• Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until End-of-study visit.
• For Subjects dependent on hemodialysis:
• Must be receiving haemodialysis session ≥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).
• Subjects will be considered not treated with erythropoietin analogue (Epoetin and Darbepoetin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR Subjects who are on ESA therapy must be on stable dose for 4 weeks prior to enrolment (≤30% of dose change).

You may not qualify if:

• Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.
• Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior to enrolment.
• In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) \> 9 %.
• In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is \>160 and 100 mm of Hg respectively or uncontrolled blood pressure.
• History of previous or concurrent cancer or renal transplant or severe allergic or hypersensitivity to investigational products and its excipients or chronic inflammatory disease (RA, Celiac disease, UC, Crohn's disease, Systemic Lupus Erythematosus \[SLE\]).
• Serologic status reflecting active Hepatits B or C infection or Human Immunodeficiency virus (HIV) infection.
• History of uncontrolled autoimmune haemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia/bleeding disorders or clinical conditions (e.g. gastrointestinal \[GI\] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding./ 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 subject safety.
• Major surgery within 90 days and minor surgery within 30 days prior to the enrolment of the subject.
• 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 myocardial infarction or stroke or intracranial haemorrhage within 6 months prior to enrolment.
• Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the NYHA (New York Heart Association) classification.
• Current life-threatening illness, medical condition, systemic disorders (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) or laboratory abnormalities which, in the Investigator's opinion, could compromise the subject's safety.
• 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).
• History of difficulty with donating blood.
• History or presence of any clinically significant ECG abnormalities during screening.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Indira Gandhi Institute of Medical Sciences

Sheikhpura, Bihar, 800014, India

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

desidustat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Deven Parmar, MD,FCP

  Zydus Therapeutics Inc.

  STUDY CHAIR

Central Study Contacts

Dr Kevin Kansagra, MD

CONTACT

02717-665555; kevinkumarkansagra@zyduslife.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: April 20, 2023
• Primary Completion: June 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)