NCT07346547

Brief Summary

A local registry on CKD-associated anemia aims to provide real-world insights into disease burden, treatment patterns, and outcomes at the national level. It helps capture variations in anemia severity with CKD stages, therapeutic practices and their response. It also supports evidence-based decision-making, identifies gaps in care, and informs locally relevant guidelines and policy planning to improve patient outcomes with oral novel therapy i.e. daprodustat

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026May 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 8, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

Daprodustatoral HIF PHICKD anemia

Outcome Measures

Primary Outcomes (1)

  • Serum hemoglobin levels

    Hemoglobin response to therapy

    3 months

Secondary Outcomes (1)

  • Frequency of MACE ( Major Adverse Cardiovascular Events)

    3 months

Study Arms (1)

Daprodustat arm for CKD anemia patients

Daprodustat arm for CKD anemia patients

Drug: Daprodustat

Interventions

Hypoxia Inducible Factor (HIF) Prolyl Hydroxylase Inhibitor (PHI) drug

Daprodustat arm for CKD anemia patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with Chronic Kidney Disease (CKD) anemia requiring anemia treatment

You may qualify if:

  • Adults ≥ 18 years 2. Diagnosed CKD-associated anemia Chronic Kidney Disease (CKD) diagnosed as per KDIGO criteria, including: CKD stages G3-G5 (based on eGFR)
  • Patients on hemodialysis (HD) or peritoneal dialysis (PD)
  • Post-kidney transplant patients with CKD 3. Receiving or initiating Daprodustat therapy (new start or switch therapy) 4. CKD stages 3-5, dialysis patients (HD/PD), or post-transplant with CKD anemia 5. Able and willing to provide informed consent

You may not qualify if:

  • Acute Kidney Injury (AKI) without underlying chronicity
  • Hematologic disorders not related to CKD (e.g hemolytic anemia, aplastic anemia)
  • Refusal or inability to provide consent
  • Current enrollment in an interventional trial that restricts real-world data collection
  • Life expectancy \< 3 months, where follow-up is not feasible
  • Known contraindications to Daprodustat as per local prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

GSK1278863

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share