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

Kidney Impairment Clinical Trial

— Kid-MaCareOnco  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308642
• Other study ID #: 2019-02143; ks19Pfister
• Status: Completed
• Start date: October 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Kidney Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel (UKBB), University of Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Stiftung für Krebskranke Kinder

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum uromodulin levels (ng/ml)	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)
Secondary	Change in serum uromodulin levels (ng/ml)	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
Secondary	Change in urine 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