Chronic Kidney Disease Stage 5 on DialysisPhase 3DREAM-DNCT04215120
Desidustat in the Treatment of Anemia in CKD on Dialysis Patients
A Phase 3 study testing Desidustat Oral Tablet and Epoetin Alfa in people with Chronic Kidney Disease Stage 5 on Dialysis, run by Zydus Lifesciences Limited at 7 sites in India.
Trial summary
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5 on Dialysis
- What is being tested?
- Desidustat Oral Tablet and Epoetin Alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 7 sitesIndia
- Study dates
- 4 Jan 2020to 2 Sep 2021
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ability to understand and give informed consent for participation. 2. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
- 3.
- Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR
- Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).
- 4. Patients on hemodialysis (≥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).
- 5. Patients with no planned change in dialysis modality and with no planned renal transplant during study period.
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- 6. Left ventricular ejection fraction ≥40% by echocardiogram prior to randomization.
- 7. No iron, folate or Vitamin B12 deficiency.
- 8. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.
Who cannot join
- Red blood cell transfusion within 8 weeks prior to participating in the study.
- History of previous or concurrent cancer.
- Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
- Active infection at initiation of study.
- History of renal transplant.
- Uncontrolled hypertension (defined as SBP >180 mmHg or DBP >100 mmHg) at screening visit (before dialysis).
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- Patient on high rhEPO dose at screening visit. [High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous].
- Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
- Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
- History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
- Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Desidustat or Epoetin alfa or to any erythropoieisis-stimulating agent.
- Pregnant and breastfeeding women.
- Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
- Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
- Presence of other clinically significant systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the Investigator's opinion, could compromise the patient'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 electrocardiogram (ECG) abnormalities during screening.
- Participants who have participated in any drug research study other than the present trial within past 3 months.
- Participants who have donated one unit (350 ml) of blood in the past 3 months or history of whole blood transfusion in last 120 days prior to entry in the study.
- Existing clinically active chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease)
- In case of DM patients, HbA1c >9%.
- Female volunteers 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 anti-fertility measures
- History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
- Positive urine pregnancy test at Visit 2
- Positive serum β-hCG level at the screening visit
- Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or history of myocardial infarction prior to first dose with study drug.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Karnavati Hospital Pvt.Ltd
Ahmedabad, Gujarat, 380006
Shalby Hospital,
Ahmedabad, Gujarat, 380015
DHS Multispecialty Hospital
Ahmedabad, Gujarat, 380054
Star Hospital
Hyderabad, Telangana, 500034
Eternal Hospital
Jaipur, Rajasthan, 302017
Chopda Medicare & Research Centre Pvt. Ltd
Nashik, Maharashtra, 422005
Aditya Birla Memorial Hospital
Pune, Maharashtra, 411033
About this study
Official title: A Phase 3, Multicenter, Open-label, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Epoetin Alfa Injection for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) on Dialysis (DREAM-D)
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)
- Being tested
- Desidustat Oral Tablet, Epoetin Alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desidustat Oral TabletDrug
Desidustat tablet
Epoetin AlfaDrug
Epoetin Injection
| Study group | Role | What they receive |
|---|---|---|
| Desidustat oral tablet | Active comparator | Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks. Receives: Drug: Desidustat Oral Tablet |
| Epoetin Injection | Experimental | Randomly assigned to receive Epoetin in a 1:1 ratio for 24 weeks. Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Change in Hb levels from baseline
Measured: 24 weeks
Secondary outcomes (2)
Hemoglobin Response
No. of subjects with Hb response
Measured: 24 weeks
Hemoglobin target range
Time to achieve target range Hb level
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start4 Jan 2020
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 5 on DialysisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 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 director, Zydus Lifesciences Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215120
- Sponsor's protocol ID
- DESI.19.001.01
- Acronym
- DREAM-D
- Status last verified
- Jan 2021
- First submitted
- 22 Dec 2019
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-label, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Epoetin Alfa Injection for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) on Dialysis (DREAM-D)
- ClinicalTrials.gov ID
- NCT04215120
- Acronym / sponsor ID
- DREAM-D / DESI.19.001.01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 2 Jan 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.
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desidustat oral tablet | Active comparator | Drug: Desidustat Oral TabletRandomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks. |
| Epoetin Injection | Experimental | Drug: Epoetin AlfaRandomly assigned to receive Epoetin in a 1:1 ratio for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Ability to understand and give informed consent for participation. 2. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
- 3.
- Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR
- Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).
- 4. Patients on hemodialysis (≥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).
Key exclusion criteria (31 listed)
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 |
|---|---|---|
| Desidustat Oral TabletDesidustat tablet | Drug | Desidustat oral tablet |
| Epoetin AlfaEpoetin Injection | Drug | Epoetin Injection |
Primary outcome
Hemoglobin level
Time frame: 24 weeks
Change in Hb levels from baseline
2 secondary outcomes
Hemoglobin Response
Time frame: 24 weeks
Hemoglobin target range
Time frame: 24 weeks
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 24 Nov 2021.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- 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 director
Zydus Lifesciences Limited
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desidustat Oral Tablet and Epoetin Alfa in people with Chronic Kidney Disease Stage 5 on Dialysis, run by Zydus Lifesciences Limited at 7 sites 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 31 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Hemoglobin level (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215120, which also lists 1 linked publication.
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 24 Nov 2021.