NCT07197957

Brief Summary

To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2025

Geographic Reach
1 country

4 active sites

Status
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 Progress59%
Mar 2025Feb 2027

Study Start

First participant enrolled

March 11, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Expected
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 25, 2025

Last Update Submit

September 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of AKI when sCr is used compared to when sCyC is used 24-48 hours after contract media and at 7-10 days follow-up

    10 days

Secondary Outcomes (1)

  • Change from baseline in eGFRcr compared to change from baseline in eGFRcys 24-48 hours after contrast media and at 7 to 10 days follow-up

    10 days

Eligibility Criteria

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

Study participants will be a cohort of inpatients with CKD. Eligible study participants, as defined by the inclusion criteria, will be consented at Morton Plant North Bay Hospital, Mease Countryside Hospital, and Morton Plant Hospital and St. Anthony's Hospital.

You may qualify if:

  • Subjects ages 18 years and above
  • Inpatients with CKD (Figure 1)
  • Order for CT imaging study or coronary angiography with isohexol Omnipaque) contrast media.
  • Pre and post contrast available
  • All races and ethnicity of patients are eligible. We expect to analyze approximately equal number of men and women in this study.

You may not qualify if:

  • Preexisting dialysis
  • Patients under the age of 18 years
  • Pregnancy
  • Incarcerated individuals
  • Patients with impaired cognition and unable to follow consent procedures
  • Recent exposure to CM (within 2 days before/after procedure)
  • Cardiac shock
  • Medications that affect biomarkers, including corticosteroids, lfamethoxazoletrimethoprim

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Morton Plant Hospital

Clearwater, Florida, 33756, United States

RECRUITING

Morton Plant North Bay Hospital

New Port Richey, Florida, 34652, United States

RECRUITING

Mease Countryside Hospital

Safety Harbor, Florida, 34695, United States

RECRUITING

St. Anthony's Hospital

St. Petersburg, Florida, 33705, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Tracy Johns, PharmD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

September 30, 2025

Study Start

March 11, 2025

Primary Completion

February 28, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations