Efficacy and Safety Evaluation of Hemoglobin Control by Erythrocyte Stimulate Agent Recommendation Algorithm in Kidney Failure with Renal Replacement Therapy

Efficacy and Safety Evaluation of Hemoglobin Control by Erythrocyte Stimulate Agent Recommendation Algorithm in Kidney Failure with Renal Replacement Therapy: Multicenter, Prospective, Single Blind, Randomization Control Trials

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0009036

Enrollment

250

Registered

2023-12-13

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This clinical trial is a “multicenter, prospective, single-blind, randomized, investigator-led, exploratory clinical trial.” When assigning subjects, the randomization is 1) hematopoi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with end-stage renal disease who have been on hemodialysis for more than 6 months - Patients with hemoglobin levels above 8.0 g/dL and below 14.0 g/dL - Patients using or planning to use Darbepoetin alpha - Adults over 19 years old and under 80 years old - Patients weighing more than 40.0 kg and less than 100.0 kg - Among the target subjects, patients whose voluntary consent procedure was confirmed after explanation of the clinical trial - Patients who can collect clinical variables for the past 5 months from the time of study registration required for algorithm operation

Exclusion criteria

Exclusion criteria: - Patients temporarily receiving hemodialysis due to acute kidney disease - Patients temporarily undergoing hemodialysis before transplantation - Patients who have experienced blood transfusion within 3 months of participating in the study - Patients with serious systemic condition - Patients with low compliance, e.g., people with mental illness - Patients withdrew from clinical trials

Design outcomes

Primary

Measure	Time frame
the rate of reaching the target hemoglobin	—

Secondary

Measure	Time frame
ESA dose/month;hemoglobin difference;success rate;failure rate;over-correction rate;transfusion;hospitalization	—

Countries

Korea, Republic of

Contacts

Public ContactHae-Ryong Yun

Yonsei University Yongin Severance Hospital

siberian82@yuhs.ac+82-31-5189-8542

Outcome results