Clinical trial · Observational
Sunitinib Treatment on Tissue Sodium Accumulation (TSS2)
Effect of Sunitinib Treatment on Tissue Sodium Accumulation in Patients With Renal Cancer: a Pilot Study
NCT04368546CI-TRIAL-00049651completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Here, it is investigated how sunitinib, a tyrosine kinase-inhibitor targeting vascular endothelial growth factor receptors, might influence sodium homeostasis in the skin and if this is related to a well-described treatment side-effect of sunitinib, hypertension.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypertension | — | UNRESOLVED | — |
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
| Sodium Imbalance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Patients
- description
- Metastatic cell carcinoma patients before sunitinib treatment, after 4 week on, after 2 week off and finally again 4 week on medication.
- interventionNames
- Drug: Sunitinib
- label
- Healthy controls
- description
- Age-matched subjects without known disease.
Primary outcomes (1)
- measure
- Skin sodium
- timeFrame
- 3 months (before, 4 weeks on, 2 weeks off and 4 weeks on medication)
- description
- Changes in sodium content measured by 23Na magnetic resonance-imaging (MRI) technique
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age men \> 18 years * Life-expectation \> 3 months * Stable weight * Blood pressure below 140/90 mmHg at baseline * Estimated glomerular filtration rate \> 45 ml/min/1.73m2 * Willingness to give written informed consent Exclusion Criteria: * Heart failure * Liver disease with ascites * Nephrotic syndrome * Gastrointestinal complaints, preventing normal daily food intake or diarrhea * Any form of diabetes mellitus * Known autoimmune diseases * Acute or chronic infection * Alcohol or substance abuse
References
Publications (4)
- BACKGROUNDKandula P, Agarwal R. Proteinuria and hypertension with tyrosine kinase inhibitors. Kidney Int. 2011 Dec;80(12):1271-7. doi: 10.1038/ki.2011.288. Epub 2011 Sep 7. PMID 21900879
- BACKGROUNDKappers MH, van Esch JH, Sluiter W, Sleijfer S, Danser AH, van den Meiracker AH. Hypertension induced by the tyrosine kinase inhibitor sunitinib is associated with increased circulating endothelin-1 levels. Hypertension. 2010 Oct;56(4):675-81. doi: 10.1161/HYPERTENSIONAHA.109.149690. Epub 2010 Aug 23. PMID 20733093
- BACKGROUNDMachnik A, Neuhofer W, Jantsch J, Dahlmann A, Tammela T, Machura K, Park JK, Beck FX, Muller DN, Derer W, Goss J, Ziomber A, Dietsch P, Wagner H, van Rooijen N, Kurtz A, Hilgers KF, Alitalo K, Eckardt KU, Luft FC, Kerjaschki D, Titze J. Macrophages regulate salt-dependent volume and blood pressure by a vascular endothelial growth factor-C-dependent buffering mechanism. Nat Med. 2009 May;15(5):545-52. doi: 10.1038/nm.1960. Epub 2009 May 3. PMID 19412173
- BACKGROUNDKopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21. PMID 23339169