NCT06587997

Brief Summary

Residual renal function (RRF) characteristically declines after patients with end-stage renal disease (ESRD) initiate dialysis. Although RRF preservation correlates with improved patient\'s quality of life and survival prospects, poor understanding of the pathophysiology underlying RRF decline limits protection strategies.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2024Sep 2026

First Submitted

Initial submission to the registry

September 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 5, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

hemodialysisrenal perfusionend-stage renal disease

Outcome Measures

Primary Outcomes (1)

  • renal perfusion

    Changes in renal perfusion during hemodialysis in patients with end-stage renal disease

    one day

Secondary Outcomes (3)

  • diastolic blood pressure

    one day

  • systolic blood pressure

    one day

  • urine volume

    10 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First Medical Center of Chinese PLA General Hospital

You may qualify if:

  • Age ≥ 18 years;
  • Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
  • Urine output \> 500ml/day or GFR \> 3ml/min/1.72m2;
  • Signed and dated informed consented is obtained.

You may not qualify if:

  • Presence of vascular access dysfunction (blood flow rate \< 180ml/min);
  • Severe heart failure;
  • Active infection;
  • Infectious disease;
  • Patients with severe anemia;
  • Patients with polycystic kidney disease;
  • Expected dialysis duration \< 6 months;
  • Pregnancy or lactation women;
  • Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
  • Unwillingness to be followed up or poor adherence to treatment;
  • Other circumstances that the investigator considers unsuitable for enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

September 5, 2024

Primary Completion (Estimated)

September 3, 2026

Study Completion (Estimated)

September 3, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09