Desidustat in the Treatment of Anemia in CKD (DREAM-ND)

November 22, 2021 updated by: Zydus Lifesciences Limited

A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis

This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
588

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Sunrise Hospital
    • Delhi
      • New Delhi, Delhi, India, 110017
        • Max Super Specialty Hospital
    • Gujarat
      • Ahmadabad, Gujarat, India
        • Thakershey Charitable trust Hospital
      • Ahmedabad, Gujarat, India, 380006
        • HCG Hospital
      • Ahmedabad, Gujarat, India, 380015
        • Sangini Hospital
      • Ahmedabad, Gujarat, India, 380025
        • GSC Medical College and Research Centre
      • Sūrat, Gujarat, India, 395009
        • BAPS Pramukh Swami Hospital
      • Vadodara, Gujarat, India, 390007
        • Sterling Hospital
      • Vadodara, Gujarat, India, 391760
        • Dhiraj General Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560090
        • Sapthagiri Institute of Medical Sciences
      • Mangalore, Karnataka, India, 575001
        • Kasturba Medical College
    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita Institute Of Medical Science
      • Kozhikode, Kerala, India, 673008
        • Government Medical College
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431003
        • Mahatma Gandhi Mission Medical College & Hospital
      • Nashik, Maharashtra, India, 422002
        • Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd)
      • Pune, Maharashtra, India, 411013
        • Noble Hospital
      • Thāne, Maharashtra, India, 401107
        • Bhaktivedanta Hospital and Research Institute
      • Thāne, Maharashtra, India, 421203
        • Asian Institute Of Medical Sciences (AIMS) Hospital
    • New Delhi
      • Delhi, New Delhi, India, 110070
        • Fortis Hospital
    • Orissa
      • Bhubaneswar, Orissa, India, 751005
        • Apollo Hospital
    • Rajasthan
      • Bīkaner, Rajasthan, India, 334003
        • Sardar Patel Medical College
      • Jaipur, Rajasthan, India, 302017
        • Eternal Hospital
      • Jaipur, Rajasthan, India, 302004
        • Sawai Man Singh (SMS) Medical College and Hospital
      • Jaipur, Rajasthan, India, 302018
        • Rukmani Birla Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500012
        • Osmania General Hospital
      • Hyderabad, Telangana, India, 500058
        • Apollo Hospital
      • Hyderabad, Telangana, India, 500082
        • Nizams Institute of Medical Sciences
      • Hyderabad, Telangana, India, 524001
        • Nizams Institute of Medical Sciences
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221311
        • Heritage Hospitals Limited
    • Uttaranchal
      • Dehradun, Uttaranchal, India, 248001
        • Shri Mahant Indiresh Hospital
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700094
        • Peerless Hospital
    • West Bangal
      • Kolkata, West Bangal, India, 700099
        • Medica Superspecialty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
  2. Ability to understand and give informed consent for participation.
  3. Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis) defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
  4. Male or female, 18 to 80 years of age.
  5. Body weight > 40 kg.
  6. Subjects not on dialysis and not expected to start dialysis during the study period.
  7. Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
  8. Estimated GFR ≥10 mL/min/1.73 m2.
  9. Serum ferritin ≥100 ng/mL and/or Transferrin Saturation >20%.
  10. No iron, folate or Vitamin B12 deficiency.
  11. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.

Exclusion Criteria:

  1. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
  2. Intravenous iron within 14 days prior to enrollment.
  3. Prior exposure of rhEPO analogues less than 04 weeks.
  4. Red blood cell transfusion within 8 weeks prior to enrollment.
  5. History of previous or concurrent cancer.
  6. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
  7. Active infection prior to enrollment.
  8. History of renal transplant.
  9. 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.
  10. 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.
  11. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
  12. 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.
  13. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  14. History of severe allergic or hypersensitivity to investigational products and its excipients.
  15. 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 patient safety.
  16. Pregnant and breastfeeding women.
  17. Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
  18. Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
  19. Presence of other 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.
  20. 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).
  21. History of difficulty with donating blood.
  22. History or presence of any clinically significant ECG abnormalities during screening.
  23. Participants who have participated in any drug research study other than the present trial within past 3 months.
  24. 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 enrollment.
  25. History of chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease, Systemic Lupus Erythematosus [SLE]).
  26. In case of Diabetes mellitus patients, glycosylated haemoglobin (HbA1c) >9 %.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Desidustat oral tablet
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
Drug: Desidustat Oral Tablet
Desidustat tablet
Experimental: Darbepoetin Alfa Injection
Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
Drug: Darbepoetin Alfa
Darbepoetin injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin level
Time Frame: 24 weeks
Change in Hb levels from baseline
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin Response
Time Frame: 24 weeks
No. of subjects with Hb response
24 weeks
Hemoglobin target range
Time Frame: 24 weeks
Time to achieve target range Hb level
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zydus Lifesciences Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: DrDeven Parmar, MD, Zydus Lifesciences Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DESI.18.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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