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

Completed

• Conditions: Kidney Impairment

• Registration Number: NCT04308642
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-16
• Study Start: 2020-10-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Children's Hospital Basel (UKBB), University of Basel; 🇨🇭 Basel, Switzerland