Chronic Kidney DiseasesPhase 4NCT05515367
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 study testing Desidustat in people with Chronic Kidney Diseases and Anemia of Chronic Kidney Disease, run by Zydus Lifesciences Limited at 1 site in India.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Anemia of Chronic Kidney Disease
- What is being tested?
- Desidustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 1 siteIndia
- Study dates
- 20 Apr 2023to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Participants who have participated in any drug research study other than the present trial within past 3 months.
- Female volunteers with following criteria will not be eligible:
- History of pregnancy or lactation in the past 3 months.
- Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures.
- History of less than 1 year of menopause and not using adequate long-term antifertility measures.
- Oral hormone replacement therapy.
- Positive serum β-hCG level at the screening visit.
- Pregnant and breastfeeding women.
- Abnormal baseline laboratory investigations as follows:
- WBC count ≤3 x 103/μL.
- Platelets count ≤100 x 103/μL.
- Bilirubin ≥2.0 mg/dL.
- ALT and/or AST ≥2.5 times of the ULN.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Indira Gandhi Institute of Medical Sciences
Sheikhpura, Bihar, 800014
Dr. Amresh Krishna, 9798773900, amreshkrishna@gmail.com
About this study
Official title: 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).
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)
Read the 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.
- Being tested
- Desidustat
- Keywords
- Real World Evidence Study
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesidustatDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Desidustat oral tablet | Experimental | Oral administration of Desidustat from baseline (week 0) to Week 52 Receives: Drug: Desidustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the Proportion of Subjects with treatment emergent adverse events.
Measured: Baseline (week 0) to Week 52 (end of treatment)
To asses the Proportion of Subjects with treatment emergent Serious adverse events.
Measured: Baseline (week 0) to Week 52 (end of treatment)
Secondary outcomes (4)
Mean change in hemoglobin level
Measured: Baseline (week 0) to Week 52 (end of treatment)
Mean change in Lipid profile including Small dense LDL from baseline
Measured: Baseline (week 0) to Week 52 (end of treatment)
Mean change in VEGF
Measured: Baseline (week 0) to Week 52 (end of treatment)
Mean change in serum Hepcidin
Measured: Baseline (week 0) to Week 52 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start20 Apr 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,004 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Deven Parmar, MD,FCP, Study chair, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515367
- Sponsor's protocol ID
- DESI.22.001
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2022
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT05515367
- Acronym / sponsor ID
- DESI.22.001
- Keywords
- Real World Evidence Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,004 participants (estimated)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desidustat oral tablet | Experimental | Drug: DesidustatOral administration of Desidustat from baseline (week 0) to Week 52 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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]).
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 |
|---|---|---|
| DesidustatOral tablet | Drug | Desidustat oral tablet |
Primary outcome
To asses the Proportion of Subjects with treatment emergent adverse events.
Time frame: Baseline (week 0) to Week 52 (end of treatment)
To asses the Proportion of Subjects with treatment emergent Serious adverse events.
Time frame: Baseline (week 0) to Week 52 (end of treatment)
4 secondary outcomes
Mean change in hemoglobin level
Time frame: Baseline (week 0) to Week 52 (end of treatment)
Mean change in Lipid profile including Small dense LDL from baseline
Time frame: Baseline (week 0) to Week 52 (end of treatment)
Mean change in VEGF
Time frame: Baseline (week 0) to Week 52 (end of treatment)
Mean change in serum Hepcidin
Time frame: Baseline (week 0) to Week 52 (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- 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.
Dr. Deven Parmar, MD,FCP study chair
Zydus Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desidustat in people with Chronic Kidney Diseases and Anemia of Chronic Kidney Disease, 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 8 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Kevin Kansagra, MD (02717-665555 ext. 451, kevinkumarkansagra@zyduslife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses the Proportion of Subjects with treatment emergent adverse events. (time frame: Baseline (week 0) to Week 52 (end of treatment)). The study lists 2 primary outcomes in all. 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 22 Jan 2025.