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NCT04442516: ACCENT

Cisplatin Induced Kidney Toxicity

Recruiting now Last updated 17 April 2024
What this trial tests

trial testing Questionnaire, sampling of blood, urine and saliva in Acute Kidney Injury in 600 participants. Currently enrolling.

Timeline
12 August 2020
Primary endpoint
1 April 2026
31 December 2028

Quick facts

Lead sponsorThe Hospital for Sick Children
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date12 August 2020
Primary completion1 April 2026
Estimated completion31 December 2028
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Acute Kidney Injury

Currently open trials in the same condition.

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Data sources for this page

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