Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy

Pilot Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy (Kid-MaCare Oncology)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04308642

Acronym

Kid-MaCareOnco

Enrollment

Registered

2020-03-16

Start date

2020-10-22

Completion date

2023-12-31

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Impairment

Keywords

nephrotoxic chemotherapy, pediatric cancer patients, renal adverse drug events, renal function, renal tubular injury, Uromodulin, drug related kidney injury, kidney markers

Brief summary

This study is to investigate blood and urine kidney injury markers (especially Uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. Uromodulin is a marker to detect and monitor tubular injury and renal function.

Interventions

OTHERblood test for renal biomarkers

blood test for renal biomarkers (uromodulin,Neutrophil gelatinase-associated lipocalin, beta-trace protein, creatinine, cystatin C)

OTHERurine test for renal biomarkers

urine test for renal biomarkers (uromodulin, alpha-1 microglobulin, retinol-binding protein, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace protein, cylinder, albumin, immunoglobulin G (IgG), transferrin, creatinine)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* signed informed consent by their-selves (≥ 14 years) or their legal representatives (\< 14 years or in case of lacking capacity of judgement) * cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs High Dose MTX (HD-MTX), ifosfamide, cis- and carboplatin.

Exclusion criteria

* critically-ill patients with inotropic and/or vasopressor drugs * signs of severe Sepsis * receiving other nephrotoxic drugs parallel to the chemotherapy cycle

Design outcomes

Primary

Measure	Time frame	Description
Change in serum uromodulin levels (ng/ml)	from baseline (i.e. prior to first nephrotoxic chemotherapy cycle) to post-baseline (i.e. at the end of the first nephrotoxic chemotherapy cycle exposure); depending on chemotherapy protocol (maximally 24 - 72 hours)	Change in serum uromodulin levels (ng/ml)

Secondary

Measure	Time frame	Description
Change in serum uromodulin levels (ng/ml)	at baseline (i.e. prior to first nephrotoxic chemotherapy cycle) and post-baseline (i.e. before, dur-ing and at the end of each nephrotoxic chemotherapy cycle),maximally 6- 9 months	Change in serum uromodulin levels (ng/ml)
Change in urine uromodulin levels (ng/ml)	at baseline (i.e. prior to first nephrotoxic chemotherapy cycle) and post-baseline (i.e. before, dur-ing and at the end of each nephrotoxic chemotherapy cycle), maximally 6- 9 months	Change in urine uromodulin levels (ng/ml)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026