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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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)

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).

NCT05515367•Zydus Lifesciences Limited

View on ClinicalTrials.gov

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)

Detailed Description

The study is being planned to evaluate long term safety of Desidustat with CKD patient. Total 1004 population i.e 502 dialysis dependent, 502 dialysis independent.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, ≥ 18 years of age.
•2. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g/dL (both inclusive) before the enrolment.
•3. Ability to understand and give informed consent for participation.
•4. No significant folate or Vitamin B12 deficiency.
•5. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until End-of-study visit.
•6. For Subjects dependent on hemodialysis:
•1. 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).
•2. 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).

Exclusion Criteria

•1. Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.
•2. Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior to enrolment.
•3. In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) \> 9 %.
•4. In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is \>160 and 100 mm of Hg respectively or uncontrolled blood pressure.
•5. 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 \[SLE\]).
•6. Serologic status reflecting active Hepatits B or C infection or Human Immunodeficiency virus (HIV) infection.
•7. 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.
•8. Major surgery within 90 days and minor surgery within 30 days prior to the enrolment of the subject.
•9. 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.
•10. History of myocardial infarction or stroke or intracranial haemorrhage within 6 months prior to enrolment.
+18 more criteria

Locations (1)

Indira Gandhi Institute of Medical Sciences

Sheikhpura, Bihar, India

Key Dates

Start Date

April 20, 2023

Primary Completion Date

June 30, 2025

Completion Date

November 30, 2025

Last Updated

January 22, 2025

Enrollment

1,004

ESTIMATED participants

Conditions

Chronic Kidney DiseasesAnemia of Chronic Kidney Disease

Interventions

Desidustat

DRUG

Contacts

Dr Kevin Kansagra, MD

CONTACT

02717-665555 kevinkumarkansagra@zyduslife.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

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