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CompletedNCT04667533Updated May 18, 2022

Desidustat in the Treatment of Chemotherapy Induced Anemia

A Phase 1 interventional study of Desidustat in Anemia of Chronic Kidney Disease and Chemotherapy Effect, sponsored by Zydus Lifesciences Limited. Completed at 1 site in India. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by Zydus Lifesciences Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anemia of Chronic Kidney Disease
  • Chemotherapy Effect

Keywords

  • Chemotherapy induced Anemia
03

In context

Lead sponsor

Zydus Lifesciences Limited is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Browse Zydus Lifesciences Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

  11. Female patients with following criteria will not be recruited:

    • History of pregnancy or lactation in the past 3 months
    • Fertile female volunteers not protected against pregnancy by adequate long-term antifertility measures
    • History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
    • Using hormone replacement therapy
    • Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
    • Positive serum β-hCG level at the screening visit

  12. Abnormal baseline laboratory investigations as follows:

    • WBC count ≤ 3 x 103/uL
    • Platelets count ≤ 100 x 103/uL
    • Bilirubin ≥ 1.5 mg/dL
    • ALT and/or AST ≥ 2.5 times of the ULN.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Desidustat tablet

    Drug: Desidustat

Interventions

  • DrugDesidustat

    A total of 24 participants will be enrolled. 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

06

What researchers measure

Primary outcomes

  1. To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.

    The Common Terminology Criteria for Adverse Event (CTCAE) (Version 4.03 or higher) system will be used for reporting and grading

    Time frame: Change from Baseline to Day 7 and Day 30

Secondary outcomes

  1. Change of hemoglobin measurement from baseline

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.

    Time frame: Change from baseline to Day 7 and Day 30

Other outcomes

  1. Maximum plasma concentration (Cmax)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  2. Time to reach maximum plasma concentration (Tmax)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  3. Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  4. Terminal half life (t1/2)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  5. Elimination rate constant (λz)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  6. Clearance (CL)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  7. Volume of distribution (Vd)

    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (\<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.

    Time frame: Change from Baseline to 72 hours in blood

  8. Amount recovered in Urine

    Urine PK collection will occur relative to dosing of Desidustat at pre-dose (within 2 hours before dosing) and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance. Desidustat and the drug metabolite in urine and additional assay may be required.

    Time frame: Change from baseline to 24 hours in urine

  9. Percent recovered in urine

    Urine PK collection will occur relative to dosing of Desidustat at pre-dose (within 2 hours before dosing) and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance. Desidustat and the drug metabolite in urine and additional assay may be required.

    Time frame: Change from baseline to 24 hours in urine

07

Study locations

1 site
  • HCG Manavata Cancer Centre,
    Nashik, Mahar Ashtra 422002, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2020 to primary completion in Mar 2022, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2020
First posted
Dec 14, 2020
StartActual
Nov 11, 2020
Primary completionActual
Mar 27, 2022
CompletionActual
May 10, 2022
Last update
May 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04667533
Lead sponsor
Zydus Lifesciences Limited
Responsible party
Sponsor
First posted
Dec 14, 2020
Start date
Nov 11, 2020
Primary completion
Mar 27, 2022
Completion
May 10, 2022
Last update
May 18, 2022

Study contacts

Dr Deven Parmar, MD
study chair · Cadila Healthcare Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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