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NCT04008810
Serum Neutrophil Gelatinase-associated Lipocalins (NGAL) and Chronic Kidney Disease
trial in Chronic Kidney Diseases in 1,032 participants. Completed in 3 June 2024.
10 January 2023
Quick facts
| Lead sponsor | Hillerod Hospital, Denmark |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,032 |
| Start date | 3 October 2019 |
| Primary completion | 10 January 2023 |
| Estimated completion | 3 June 2024 |
| Sites | 1 location across Denmark |
Conditions studied
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
- CKD — all drugs for CKD →
- NGAL — all drugs for NGAL →
- Neutrophil Gelatinase-associated Lipocalin — all drugs for Neutrophil Gelatinase-associated Lipocalin →
Sponsor
Hillerod Hospital, Denmark
Who can join
18 and older, any sex, with Chronic Kidney Diseases or CKD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute kidney injury (AKI) is associated with significant morbidity and mortality, and because no specific treatment is available, early acknowledgment is needed. The incidence of AKI and chronic kidney disease (CKD) have been increasing over time but it is not until the past decade there is an understanding of a bidirectional nature between AKI and CKD, where AKI predisposes to CKD and vice versa. The criteria for diagnosing AKI is through serum creatinine (sCr) and/or urine output. As detection of sCr-increases are delayed by 48-72 hours it is not an optimal biomarker for early recognition of AKI. In contrast the biomarker neutrophil gelatinase-associated lipocalin (NGAL) has shown to predict AKI within 12h of critical disease or postoperative, and without the requirement of prior measurements for comparison. The purpose of the project is to investigate if the relatively new biomarker NGAL (neutrophil gelatinase-associated lipocalin), which is known to be able to detect AKI in an early phase, can be used to detect development of CKD and potential future hospital admissions in a relatively large and diverse cohort of patients admitted to the Acute Emergency Department at North Zealand Hospital. The study is designed as a longitudinal prospective study where there is an enrollment estimation of 3600 unselected patients over one year. Blood tests will be taken when admitted and thereafter every day for the first week and subsequently every once a week throughout hospitalization. Patients that are sent home the same day, will still be included in the study but without further NGAL analyses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04008810
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other Hillerod Hospital, Denmark trials
Trials by the same sponsor.
- NCT06399146 — Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana · NA · recruiting
- NCT03268967 — Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM) · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04008810 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hillerod Hospital, Denmark
- Last refreshed: 25 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04008810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing