NCT04227158

Brief Summary

Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but \<35 pg and RBC ≤350×104/μL; and MCH \<30 pg and RBC \>350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

November 4, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

January 9, 2020

Last Update Submit

November 2, 2020

Conditions

Renal Anemia

Keywords

red blood cellmean corpuscular hemoglobinhemoglobinHemodialysis patients

Outcome Measures

Primary Outcomes (1)

  • Survival rate between high or low RBC group (all cause death)

    Survival curves for 3-year survival, based on all available follow-up data, will perform with the use of Kaplan-Meier estimates and will be compared between groups with the use of the log-rank test, and used Holm's method as post hoc.

    three years (retrospectively)

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients has undergone maintenance Hemodialysis for \>1 year.

You may qualify if:

  • Patients will be controlled with hemoglobin levels between ≥10 g/dL and \<12 g/dL and had undergone maintenance HD for \>1 year.

You may not qualify if:

  • Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Applied Informatics, University of Hyogo

Kobe, Hyōgo, 650-0047, Japan

Location

Study Officials

  • Yuko MIZUNO, Ph.D.

    University of Hyogo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
visiting researche, Yoshihiro Tsuji

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

April 20, 2020

Primary Completion

August 20, 2020

Study Completion

August 20, 2020

Last Updated

November 4, 2020

Record last verified: 2020-03

Locations

JP(1)