Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients

NCT06463236 | Recruiting

• 1 other identifier: 01
• Study Type: interventional
• Target: 1,296
• Locations: 1 country
• Sites: 1

Brief Summary

This test aims to verify that the management process of renal anemia in maintenance hemodialysis patients can improve the hemoglobin compliance rate better than that of anemia management by primary doctors, and promote the system at the grassroots level to guide primary doctors in anemia management and improve the management standard of renal anemia in maintenance hemodialysis patients through prospective randomized controlled trials. To improve the anemia compliance rate of maintenance hemodialysis patients, and to improve the basic doctors' grasp of the anemia management guidelines, consensus and standard operating procedures.

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Changes in the one-year compliance rate of renal anemia

  Changes in renal anemia compliance rates between the experimental group and the control group within one year

  one year

Study Arms (2)

Intervention group

EXPERIMENTAL

Standardized guidance for anemia treatment by grassroots doctors using the maintenance hemodialysis renal anemia management process

Other: Guiding treatment

control group

ACTIVE COMPARATOR

Experiential treatment by grassroots doctors

Other: empirical therapy

Interventions

Guiding treatment OTHER

Standardized guidance for anemia treatment by grassroots doctors using the maintenance hemodialysis renal anemia management process

Intervention group

empirical therapy OTHER

Experiential treatment by grassroots doctors

control group

Eligibility Criteria

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

You may qualify if:

• ① Age over 18 years old; ② Receive regular hemodialysis at least twice a week for at least 3 months, and have no plans to stop hemodialysis within 6 months since the start of the trial; ③ The patient voluntarily participated in this study.

You may not qualify if:

• Patients who have planned to undergo kidney transplantation or terminate hemodialysis during the study period; ② Previous history of bone marrow hematopoietic system diseases, such as combined myelodysplastic syndrome, multiple myeloma, and other diseases; ③ Any known hereditary blood disease, such as thalassemia, sickle cell anemia, pure red blood cell aplasia, etc.; ④ Active or chronic gastrointestinal bleeding; ⑤ There was a severe infection within one week prior to screening.

Sponsors & Collaborators

• Hong Daqing: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Central Study Contacts

Daqing Hong

CONTACT

17716168101; hongdaqing11@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 14, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CN (1)