Spinal Cord InjuriesNCT06565351
S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries
An observational study of Spinal Cord Injuries and Renal Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Renal Failure
- What is being tested?
- eGFR estimated from creatinine and cystatin C
- How many people
- 248 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Neurogenic bladder dysfunction due to spinal cord injury
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet; Glostrup
Glostrup Municipality, DK-2600
About this study
Official title: 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
- Conditions
- Spinal Cord Injuries, Renal Failure
- Being tested
- eGFR estimated from creatinine and cystatin C
- Keywords
- spinal cord injury, renal Failure, GFR, Glomerular filtration rate, DTPA clearance, Cystatin C, eGFR
- Medical subject headings
- Spinal Cord Injuries, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eGFR estimated from creatinine and cystatin COther
eGFR estimated from creatinine and cystatin C was compared to GFR measured by 99mTc-DTPA clearance (gold standard)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: eGFR estimated from creatinine and cystatin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study period (2 years)
Secondary outcomes (2)
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
Measured: 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
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jun 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrik Bjoern Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulrik B. Andersen, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565351
- Sponsor's protocol ID
- Rigshospitalet; Glostrup
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Replacing 99mTc-DTPA GFR Measurements With eGFR From s-Cystatin C in Individuals With Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT06565351
- Acronym / sponsor ID
- Rigshospitalet; Glostrup
- Conditions
- Spinal Cord Injuries, Renal Failure
- Keywords
- spinal cord injury, renal Failure, GFR, Glomerular filtration rate, DTPA clearance, Cystatin C, eGFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury Individuals | – | Other: eGFR estimated from creatinine and cystatin C248 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Neurogenic bladder dysfunction due to spinal cord injury
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eGFR estimated from creatinine and cystatin CeGFR estimated from creatinine and cystatin C was compared to GFR measured by 99mTc-DTPA clearance (gold standard) | Other | Spinal Cord Injury Individuals |
Primary outcome
Estimated clearance of Cystatin C (eGFR cystatin C)
Time frame: 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
2 secondary outcomes
Test/ retest variability of eGFR cystatin C
Time frame: Up to three months
Long term repeatability of eGFR cystatin C
Time frame: Up to three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik B. Andersen principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Renal Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated clearance of Cystatin C (eGFR cystatin C) (time frame: through study period (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.