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

Rekrutierend

NCT-Nummer:
NCT04308642

Studienbeginn:
Oktober 2020

Letztes Update:
02.03.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Drug-Related Side Effects and Adverse Reactions

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
Stiftung für Krebskranke Kinder

Studienleiter

Marc Pfister, Prof MD
Principal Investigator
University Children's Hospital Basel (UKBB), University of Basel

Kontakt

Marc Pfister, Prof MD
Kontakt:
Phone: 0041 61 704 1851
E-Mail: Marc.Pfister@ukbb.ch» Kontaktdaten anzeigen

Tatjana Welzel, MD
Kontakt:
E-Mail: Tatjana.Welzel@ukbb.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Children's Hospital Basel (UKBB), University of Basel
4056 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Marc Pfister, Prof. MD
Phone: 0041 61 704 1851
E-Mail: Marc.Pfister@ukbb.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change in serum uromodulin levels (ng/ml) (Time Frame - 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:

1. Change in serum uromodulin levels (ng/ml) (Time Frame - 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)

2. Change in urine uromodulin levels (ng/ml) (Time Frame - 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)

Geprüfte Regime

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)

Quelle: ClinicalTrials.gov