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

• 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

Study Overview

• Status: Completed
• Conditions: Renal Failure; Spinal Cord Injuries
• Intervention / Treatment: Other: eGFR estimated from creatinine and cystatin C

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, DK-2600
    • Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet; Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

248 consecutive individuals with neurogenic bladder dysfunction due to spinal cord injury coming to routine control of their kidney function every 2-3 years according to international guidelines

Description

Inclusion Criteria:

Neurogenic bladder dysfunction due to spinal cord injury

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal Cord Injury Individuals; 248 individuals with spinal cord injury and neurogenic bladder dysfunction, coming to routine controls of the renal function. Glomerular filtration rate (GFR) was measured by 99mTc-DTPA clearance and estimated by eGFR from creatinine and Cystatine C	Other: eGFR estimated from creatinine and cystatin C; eGFR estimated from creatinine and cystatin C was compared to GFR measured by 99mTc-DTPA clearance (gold standard)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated clearance of Cystatin C (eGFR cystatin C)	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	through study period (2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test/ retest variability of eGFR cystatin C	Blood samples for determination of Cystatin C is taken twice within maximally three months, to determine the repeatability of eGFR cystatin C	Up to three months
Long term repeatability of eGFR cystatin C	Blood 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	Up to three years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Ulrik B. Andersen, Rigshospitalet: Glostrup

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Glomerular filtration rate; spinal cord injury; eGFR; Cystatin C; GFR; renal Failure; DTPA clearance
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Trauma, Nervous System; Spinal Cord Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Renal Insufficiency; Spinal Cord Injuries; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Cystatins
• Other Study ID Numbers: Rigshospitalet; Glostrup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers. Data or samples shared will be coded, with no personal health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: 9-24 months after publication
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No