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Desidustat in the Treatment of Anemia in CKD

NCT04012957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2021-11-24

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Desidustat Oral Tablet

Desidustat tablet

DRUG

Darbepoetin Alfa

Darbepoetin injection

Sponsors & Collaborators

Principal Investigators

  • DrDeven Parmar, MD · Zydus Lifesciences Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-20
Primary Completion
2021-08-25
Completion
2021-08-25

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04012957 on ClinicalTrials.gov