Last reviewed · How we verify
NCT04442516: ACCENT
Cisplatin Induced Kidney Toxicity
trial testing Questionnaire, sampling of blood, urine and saliva in Acute Kidney Injury in 600 participants. Currently enrolling.
1 April 2026
Quick facts
| Lead sponsor | The Hospital for Sick Children |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 12 August 2020 |
| Primary completion | 1 April 2026 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Questionnaire, sampling of blood, urine and saliva
Conditions studied
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
- Cancer — all drugs for Cancer →
Sponsor
The Hospital for Sick Children
Who can join
3 Months and older, any sex, with Acute Kidney Injury or Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cisplatin (CisP) is a chemotherapeutic agent used to treat head and neck and lung cancer in adults and over 15 different pediatric cancers. Despite its known toxicity, CisP is still widely used as a first line chemotherapy as it is so effective. Nephrotoxicity is one of the most common adverse effects of CisP, occurring in 20-50% of patients. It manifests as acute kidney injury (AKI) typically within the first few days of exposure and is associated with short and long-term morbidity. Furthermore, AKI diagnosis is only possible once kidney damage has progressed to functional impairment, when mitigation strategies are ineffective. Tests that could predict AKI risk pre-emptively or diagnose early-stage AKI before functional loss would be very impactful, affording opportunities for prevention or early intervention to mitigate CisP nephrotoxicity, reduce morbidity and improve health outcomes. The field of metabolomics seeks to identify patterns of small molecules (metabolites) involved in cell or tissue metabolism related to disease states, or patient factors like lifestyle and genetics. Plasma and urine are ideal for sampling the metabolome, which can identify at-risk patients and reveal disease-related changes earlier than existing diagnostic methods do. In CisP-treated children and adults from across Canada, we will identify urine and plasma metabolite profiles a) prior to CisP dosing that predict CisP AKI risk, and b) shortly after dosing to identify early-stage nephrotoxicity, before clinical signs of AKI are detectable. Our identified biomarkers will allow individualization of CisP treatment based on the level of nephrotoxicity risk and the design of trials to mitigate the progression and complications of CisP nephrotoxicity.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Canadian Study of Cisplatin Metabolomics and Nephrotoxicity (ACCENT): A Clinical Research Protocol.
Jain A, Huang R, Lee J, Jawa N, et al · · 2021 · cited 4× · PMID 34820133 · DOI 10.1177/20543581211057708
Verify or expand the search:
- PubMed search for NCT04442516
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04442516 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Hospital for Sick Children
- Last refreshed: 17 April 2024
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/NCT04442516.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing