Anemia of Chronic Kidney DiseasePhase 1NCT04667533
Desidustat in the Treatment of Chemotherapy Induced Anemia
A Phase 1 study testing Desidustat in people with Anemia of Chronic Kidney Disease and Chemotherapy Effect, run by Zydus Lifesciences Limited at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease, Chemotherapy Effect
- What is being tested?
- Desidustat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 11 Nov 2020to 10 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-myeloid malignancy.
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male and Female patients at least 18 years old at the time of signing the ICF.
- Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.
- Subjects with eGFR >60 mL/min/1.73 meter sequre at screening.
- Weight should be ≥50 kg.
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- Willingness to participate after informed consent.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Ability to swallow and retain oral medication.
Who cannot join
- Known hypersensitivity to Desidustat and excipients in the investigational drug product.
- History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
- History of RBC transfusion <4 weeks prior enrollment.
- History or presence of any clinically significant electrocardiogram abnormalities during screening.
- 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
- Major illness and/or major surgery in the last 3 months.
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- Planned elective surgery during the study
- Receiving or has received any investigational drug within the 30 days before receiving Desidustat.
- Any participants with poor peripheral venous access.
- A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening visit.
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
- Cohort I: Single-dose 100 mg
- Cohort II: Single-dose 150 mg
- 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.
- Being tested
- Desidustat
- Keywords
- Chemotherapy induced Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesidustatDrug
A total of 24 participants will be enrolled.
The study is divided into three cohorts as given below:
- Cohort I: Single-dose 100 mg
- Cohort II: Single-dose 150 mg
- Cohort III: Single-dose 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Desidustat tablet | Experimental | Not described Receives: Drug: Desidustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Change from baseline to Day 7 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start11 Nov 2020
- Primary completion27 Mar 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Deven Parmar, MD, Study chair, Cadila Healthcare Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667533
- Sponsor's protocol ID
- DESI.20.001
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04667533
- Acronym / sponsor ID
- DESI.20.001
- Keywords
- Chemotherapy induced Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Cohort I: Single-dose 100 mg
- Cohort II: Single-dose 150 mg
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desidustat tablet | Experimental | Drug: Desidustat |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of non-myeloid malignancy.
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male and Female patients at least 18 years old at the time of signing the ICF.
- Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.
- Subjects with eGFR >60 mL/min/1.73 meter sequre at screening.
Key exclusion criteria (22 listed)
- Known hypersensitivity to Desidustat and excipients in the investigational drug product.
- History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
- History of RBC transfusion <4 weeks prior enrollment.
- History or presence of any clinically significant electrocardiogram abnormalities during screening.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesidustatA 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 | Drug | Desidustat tablet |
Primary outcome
To evaluate Adverse event of Desidustat following 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
The Common Terminology Criteria for Adverse Event (CTCAE) (Version 4.03 or higher) system will be used for reporting and grading
1 secondary outcome
Change of hemoglobin measurement from baseline
Time frame: Change from baseline to Day 7 and Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Deven Parmar, MD study chair
Cadila Healthcare Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desidustat in people with Anemia of Chronic Kidney Disease and Chemotherapy Effect, run by Zydus Lifesciences Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate Adverse event of Desidustat following 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.