Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients

NCT05032651 | Unknown DMC

• 1 other identifier: KMUHIRB-F(I)-20210040
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboembolic event, which leaded current guidelines to recommend the therapeutic goal for anemia in ESRD should be within a range (usually between 10-12 gm/dl) rather than above or below a certain level (or value). In addition to ESA dose, many factors contribute to the severity of anemia in this population, such as iron status, chronic blood loss, adequacy of dialysis, chronic inflammation, renal wasting, et al. To put all these factors together, maintaining the Hb levels within the target level is a challenge to physician. It was reported that only one third of Hb within the target at any given time. Our data showed, for those under maintenance hemodialysis and without any blood transfusion in observation period, near two third of patients' Hb level were within the target range.

Conditions

End Stage Renal Disease on Dialysis

Keywords

End Stage Renal Disease; Erythropoiesis stimulating agent; Artificial intelligence assisted platform

Outcome Measures

Primary Outcomes (1)

• hemoglobin (Hb) levels

  Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.

  6 monthes

Secondary Outcomes (2)

• the target range (10-12gm/dl)

  6 monthes

• The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion

  6 monthes

Study Arms (2)

GROUP A-AI (model) Arm Description:

EXPERIMENTAL

Artificial intelligence assisted platform supported system for the clinical physicians to prescribe ESA dose to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.

Device: novel artificial intelligence assisted platform

GROUP B-AI (model) Arm Description:

EXPERIMENTAL

ESA dose prescribed by clinical physicians as regular care to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.

Device: novel artificial intelligence assisted platform

Interventions

novel artificial intelligence assisted platform DEVICE

Use of a novel artificial intelligence assisted platform

GROUP A-AI (model) Arm Description:; GROUP B-AI (model) Arm Description:

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• Age older than 20 year old.
• End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours
• Having at least consecutive 6 months data of both Hb and biochemical study during dialysis before enrollment and at least one Hb level within the range of 11-12 g/dl
• Having at least one prescription of ESA supplement to keep Hb within the range of 10-12 g/dl in the past 6 months before the enrollment
• Having received ESA of the same brand at least 6 months before the enrollment

You may not qualify if:

• Ever receiving blood transfusion in the past 12 months
• Active bleeding with blood loss more than 250cc in 3 months before the enrollment
• Active infection or malignancy
• Study subject can not follow with the study protocol
• End of Study
• The eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria:

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• National Sun Yat-sen University: collaborator

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping-Hsun Wu

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping-Hsun Wu, PhD

CONTACT

07-3121101; 970392KMUH@gmail.com

YI-PEI CHEN

CONTACT

07-3121101; joanna9504@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization period All eligible subjects will be randomized 1:1 by their age, gender, and HD vintage into control arm and intervention arm. After randomization, the study subject will enter the study after the nearest Hb measurement coming. Study period

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 2, 2021
• Study Start: March 19, 2021
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: October 13, 2021

Record last verified: 2021-06

Locations

TW (1)