Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

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)

Desidustat oral tablet

ACTIVE COMPARATOR

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

Drug: Desidustat Oral Tablet

Epoetin Injection

EXPERIMENTAL

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

Drug: Epoetin Alfa

Interventions

Desidustat Oral TabletDrug

Desidustat tablet

Desidustat oral tablet

Epoetin AlfaDrug

Epoetin Injection

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

\. Ability to understand and give informed consent for participation. 2. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
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

Sponsors & Collaborators

Zydus Lifesciences Limited
Industrylead

Study Sites (7)

Karnavati Hospital Pvt.Ltd

Ahmedabad, Gujarat, 380006, India

Shalby Hospital,

Ahmedabad, Gujarat, 380015, India

DHS Multispecialty Hospital

Ahmedabad, Gujarat, 380054, India

Chopda Medicare & Research Centre Pvt. Ltd

Nashik, Maharashtra, 422005, India

Aditya Birla Memorial Hospital

Pune, Maharashtra, 411033, India

Eternal Hospital

Jaipur, Rajasthan, 302017, India

Star Hospital

Hyderabad, Telangana, 500034, 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

Interventions

desidustatEpoetin Alfa

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

Dr Deven Parmar, MD
Zydus Lifesciences Limited
STUDY DIRECTOR

Enrollment

392 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

December 22, 2019

First Posted

January 2, 2020

Study Start

January 4, 2020

Actual (reported)

Desidustat in the Treatment of Anemia in CKD on Dialysis Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Desidustat oral tablet

Epoetin Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

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

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Desidustat oral tablet

Epoetin Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations