NCT06996717

Brief Summary

The study will assess role of rule based algorithm in anemia management in hemodialysis patients and its relation to patient's mortality

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

May 6, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Increase the number of patients in the target Hb range

    This study will achieve better dosing of erythropoietin stimulating agents using rule based algorithms to correct anemia and avoid unnecessary extra doses of erythropoietin stimulating agents with their side effects

    6 months

Study Arms (1)

end stage renal disease patients

EXPERIMENTAL

management of different hemoglobin levels by erythropoietin stimulating agents according to expert opinion and according to algorithm

Drug: ESA

Interventions

ESADRUG

anemia management algorithm will successfully increase the number of patients in the target hemoglobin range

end stage renal disease patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients on hemodialysis for more than six months patients undergoing hemodialysis three times per week each session for 4 hours patients with urea reduction ratio\>65% patients with transferrin saturation\>20%

You may not qualify if:

  • patients with terminal illness or malignancy patients receiving hemodialysis from catheter or arteriovenous graft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemodialysis Units in Ain Shams University Hospitals

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 30, 2025

Study Start

January 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

May 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations