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Desidustat in the Treatment of Chemotherapy Induced Anemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Desidustat in the Treatment of Chemotherapy Induced Anemia

A Phase 1, Open-Label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for Treatment of Anemia in Patients Receiving Chemotherapy

NCT04667533•Zydus Lifesciences Limited

View on ClinicalTrials.gov

Summary

This is a Phase 1, Open-label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for treatment of anemia in patients receiving chemotherapy.

Detailed Description

A total of up to approximately 24 patients will be enrolled to receive Desidustat in an open-label manner. The study is divided into three cohorts as given below: 1. Cohort I: Single-dose 100 mg 2. Cohort II: Single-dose 150 mg 3. Cohort III: Single-dose 200 mg Note:- After evaluation of PK data of 100 mg dose cohort, next cohort with higher dose will be decided. Maximum dose of Desidustat will not be exceeded than 200 mg. First cohort will be given 100 mg single dose of Desidustat. On completion of safety and PK evaluation of first cohort,the next cohort with escalated single dose (150 mg) of Desidustat will be initiated. Similar way third cohort with 200 mg single dose will be initiated after safety evaluation of 150 mg cohort data.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of non-myeloid malignancy.
•2. Ability to comprehend and willingness to sign a written ICF for the study.
•3. Male and Female patients at least 18 years old at the time of signing the ICF.
•4. Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.
•5. Subjects with eGFR \>60 mL/min/1.73 meter sequre at screening.
•6. Weight should be ≥50 kg.
•7. Willingness to participate after informed consent.
•8. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
•9. Ability to swallow and retain oral medication.

Exclusion Criteria

•1. Known hypersensitivity to Desidustat and excipients in the investigational drug product.
•2. History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
•3. History of RBC transfusion \<4 weeks prior enrollment.
•4. History or presence of any clinically significant electrocardiogram abnormalities during screening.
•5. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening
•6. Major illness and/or major surgery in the last 3 months.
•7. Planned elective surgery during the study
•8. Receiving or has received any investigational drug within the 30 days before receiving Desidustat.
•9. Any participants with poor peripheral venous access.
•10. A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening visit.
+12 more criteria

Locations (1)

HCG Manavata Cancer Centre,

Nashik, Mahar Ashtra, India

Key Dates

Start Date

November 11, 2020

Primary Completion Date

March 27, 2022

Completion Date

May 10, 2022

Last Updated

May 18, 2022

Enrollment

ACTUAL participants

Conditions

Anemia of Chronic Kidney DiseaseChemotherapy Effect

Interventions

Desidustat

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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: May 18, 2022Data 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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Desidustat in the Treatment of Chemotherapy Induced Anemia

Inclusion Criteria

Exclusion Criteria

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