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Renal toxicity during cancer treatment with angiogenesis inhibitors


- candidate number22318
- NTR NumberNTR5244
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2015
- Secondary IDsMHWK01 METC has approved the project, but did not assign an ID
- Public TitleRenal toxicity during cancer treatment with angiogenesis inhibitors
- Scientific TitleRenal toxicity during angiogenesis inhibition:predicting factors, early detection and timely treatment
- ACRONYM
- hypothesisWe hypothesize that podocyturia is an early marker of ongoing renal damage during angiogenesis inhibition.
- Healt Condition(s) or Problem(s) studiedKidney damage
- Inclusion criteria- Patients with malignancy treated with an anti-VEGF monoclonal antibody or receptor tyrosine kinase inhibitor (RTKI) + chemotherapy
- Patients treated with chemotherapy alone (without an anti-VEGF monoclonal antibody or RTKI) = control group 1
- 'Healthy' patients without malignancy and normal kidney function (MDRD > 60 ml/min) without proteinuria (see also exclusion criteria) = control group 2
- Exclusion criteria- Healthy controls (control group 2) with abnormal kidney function and/or proteinuria (protein-to-creatinine ratio > 45 mg/mmol or albumin-to-creatinine ratio > 30 mg/mmol)
- Known renal insufficiency (MDRD < 60 ml/min) in patients with malignancy and/or proteinuria (protein-to-creatinine ratio > 45 mg/mmol or albumin-to-creatinine ratio > 30 mg/mmol) if this latter has been previously reported
- Previous therapy with an anti-VEGF monoclonal antibody or RTKI
- Concomitant chemotherapy frequently associated with renal injury (>10% of patients), e.g. cisplatinum
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate1-apr-2017
- Target number of participants90
- InterventionsSixty patients treated with an anti-VEGF monoclonal antibody or RTKI at the department of Oncology of the Amphia hospital will be invited to participate in our study. During a routine visit at the outpatient clinic a morning spot urine sample will be collected cross-sectionally during treatment to measure podocyturia. Also blood pressure will be measured. Furthermore, patients characteristics will be collected. Since treatment with an angiogenesis inhibitor is often combined with chemotherapy, in a comparable group of 20 patients treated with this chemotherapy without an angiogenesis inhibitor, urine samples will be collected to assess podocyturia (= control group 1). Likewise, podocyturia will be determined in 10 'healthy' (control) subjects who visit the outpatient clinic for other medical issues (e.g. analysis of fatigue, abdominal pain, etc. [ = control group 2]).
- Primary outcomeIncidence of podocyturia during treatment with an angiogenesis inhibitor
- Secondary outcomethe correlation between podocyturia and proteinuria, the correlation between podocyturia and renal function, the correlation between podocyturia and blood pressure, the effect of angiotensin converting enzyme inhibitors (ACEi) on podocyturia
- TimepointsCross-sectionally during treatment with an angiogenesis inhibitor or chemotherapy a spot urine sample will be collected once.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. M.H.W. Kappers
- CONTACT for SCIENTIFIC QUERIESDr. M.H.W. Kappers
- Sponsor/Initiator Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Stichting Mitialto, Roche
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-jun-2015 - 21-sep-2017


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