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S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries

Feasibility of Replacing 99mTc-DTPA GFR Measurements With eGFR From s-Cystatin C in Individuals With Spinal Cord Injuries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06565351
Enrollment
248
Registered
2024-08-21
Start date
2020-06-01
Completion date
2022-01-01
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure, Spinal Cord Injuries

Keywords

spinal cord injury, renal Failure, GFR, Glomerular filtration rate, DTPA clearance, Cystatin C, eGFR

Brief summary

* In individuals with spinal cord injury (SCI) kidney function defined as Glomerular Filtration Rate (GFR) is monitored by injection of e.g.99mDTPA and subsequent blood sampling (DTPA-clearance) * GFR calculated from plasma samples of the endogenous substance s-Cystatin C (eGFR cystatin C) was compared to DTPA-clearance in 248 individuals with SCI. * It is concluded that eGFR based on plasma s-cystatin C can replace the more tedious 99mDTPA-clearance procedures in individuals with SCI

Interventions

OTHEReGFR estimated from creatinine and cystatin C

eGFR estimated from creatinine and cystatin C was compared to GFR measured by 99mTc-DTPA clearance (gold standard)

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Neurogenic bladder dysfunction due to spinal cord injury

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Estimated clearance of Cystatin C (eGFR cystatin C)through study period (2 years)The estimated clearance of cystatin (eGFR) C is calculated from s-cystatin C and the age and height and weight of the individual. It is corrected for Body Surface area. In this study it is compared to the Gold Standard examination DTPA-clearance

Secondary

MeasureTime frameDescription
Test/ retest variability of eGFR cystatin CUp to three monthsBlood samples for determination of Cystatin C is taken twice within maximally three months, to determine the repeatability of eGFR cystatin C
Long term repeatability of eGFR cystatin CUp to three yearsBlood samples for determination of cystatin C is taken twice with an interval of two-three years to determine long term repeatability. This is compared to simultaneously acquired measurements of DTPA-clearance

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026