Completed

DREAM-NDDesidustat vs Darbepoetin for Anemia in Non-Dialysis Chronic Kidney Disease Patients

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Study Aim

This study aims to compare the effectiveness of Desidustat and Darbepoetin in treating anemia by observing changes in hemoglobin levels in non-dialysis chronic kidney disease patients.

What is being tested

Desidustat Oral Tablet

+ Darbepoetin Alfa

Drug
Who is being recruted

Urogenital Diseases+12

+ Anemia

+ Chronic Disease

From 18 to 80 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2019
See protocol details

Summary

Principal SponsorZydus Lifesciences Limited
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2019

Actual date on which the first participant was enrolled.

This clinical trial is all about comparing two treatments for anemia in people who have Chronic Kidney Disease (CKD) but are not on dialysis. The two treatments are Desidustat and Darbepoetin. The main goal is to see which one works better and is safer. This is important because it could help improve care for people with CKD and anemia, a common condition that can make people feel tired and weak due to a lack of healthy red blood cells. During this trial, participants receive either Desidustat or Darbepoetin over a period of up to 30 weeks. The study measures the change in hemoglobin levels, a protein in red blood cells that carries oxygen, from the start to the end of the trial. This helps determine how well each treatment improves anemia. As with any study, there may be potential risks and benefits, which are carefully monitored throughout the trial.

Official TitleA 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
NCT04012957
Principal SponsorZydus Lifesciences Limited
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

588 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAnemiaChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

11 inclusion criteria required to participate
Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
Ability to understand and give informed consent for participation.
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.
Male or female, 18 to 80 years of age.
Show More Criteria
26 exclusion criteria prevent from participating
History of severe allergic or hypersensitivity to investigational products and its excipients.
Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
Intravenous iron within 14 days prior to enrollment.
Prior exposure of rhEPO analogues less than 04 weeks.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.

Group II

Experimental
Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Suspended

Sunrise Hospital

Vijayawada, IndiaOpen Sunrise Hospital in Google Maps
Suspended

HCG Hospital

Ahmedabad, India
Suspended

Sangini Hospital

Ahmedabad, India
Suspended

GSC Medical College and Research Centre

Ahmedabad, India
Completed32 Study Centers
DREAM-ND | Desidustat vs Darbepoetin for Anemia in Non-Dialysis Chronic Kidney Disease Patients | PatLynk