Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Kidney Disease Stage 3 Anemia Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5

Keywords

DREAM-ND

Outcome Measures

Primary Outcomes (1)

Hemoglobin level
Change in Hb levels from baseline
24 weeks

Secondary Outcomes (2)

Hemoglobin Response
24 weeks
Hemoglobin target range
24 weeks

Study Arms (2)

Darbepoetin Alfa Injection

EXPERIMENTAL

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

Drug: Darbepoetin Alfa

Desidustat oral tablet

ACTIVE COMPARATOR

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

Drug: Desidustat Oral Tablet

Interventions

Desidustat Oral TabletDrug

Desidustat tablet

Desidustat oral tablet

Darbepoetin AlfaDrug

Darbepoetin injection

Darbepoetin Alfa Injection

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Zydus Lifesciences Limited
Industrylead

Study Sites (32)

Sunrise Hospital

Vijayawada, Andhra Pradesh, 520002, India

HCG Hospital

Ahmedabad, Gujarat, 380006, India

Sangini Hospital

Ahmedabad, Gujarat, 380015, India

GSC Medical College and Research Centre

Ahmedabad, Gujarat, 380025, India

Thakershey Charitable trust Hospital

Ahmedabad, Gujarat, India

BAPS Pramukh Swami Hospital

Surat, Gujarat, 395009, India

Sterling Hospital

Vadodara, Gujarat, 390007, India

Related Publications (1)

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.
PMID: 36005278DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicAnemia

Interventions

desidustatDarbepoetin alfa

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

DrDeven Parmar, MD
Zydus Lifesciences Limited
STUDY DIRECTOR

Enrollment

588 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

July 9, 2019

Study Start

July 20, 2019

Actual (reported)

Primary Completion

Desidustat in the Treatment of Anemia in CKD

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Darbepoetin Alfa Injection

Desidustat oral tablet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Darbepoetin Alfa Injection

Desidustat oral tablet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations