NCT06287879

Brief Summary

Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592). Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms. This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 1, 2024

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

February 1, 2024

Last Update Submit

February 27, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Lacrimal river height

    Measured by dry eye analyzer machine

    Immediately and six months later

  • tear break-up time

    Measured by dry eye analyzer machine

    Immediately and six months later

  • tear-film lipid layer thickness

    Measured by dry eye analyzer machine

    Immediately and six months later

  • meibomian glands two-dimensional digital infrared images

    Measured by dry eye analyzer

    Immediately and six months later

Study Arms (2)

Roxadustat

EXPERIMENTAL

Subjects were treated with Roxadustat for renal anemia

Diagnostic Test: Dry eye examination

EPO

ACTIVE COMPARATOR

Subjects were treated with EPO for renal anemia

Diagnostic Test: Dry eye examination

Interventions

Dry eye examinationDIAGNOSTIC_TEST

1. Lacrimal river height 2. tear break-up time 3. tear-film lipid layer thickness 4. meibomian glands two-dimensional digital infrared images

EPORoxadustat

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • long-term use of Roxadustat or erythropoietin for renal anemia

You may not qualify if:

  • contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

March 1, 2024

Study Start

April 1, 2023

Primary Completion

December 20, 2024

Study Completion

December 30, 2024

Last Updated

March 1, 2024

Record last verified: 2023-11

Locations