NCT04368546

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

April 27, 2020

Last Update Submit

January 25, 2021

Conditions

Renal Cell Cancer MetastaticHypertensionSodium Imbalance

Keywords

SunitinibTyrosine kinases-inhibitorSodiumMRISkin

Outcome Measures

Primary Outcomes (1)

  • Skin sodium

    Changes in sodium content measured by 23Na magnetic resonance-imaging (MRI) technique

    3 months (before, 4 weeks on, 2 weeks off and 4 weeks on medication)

Secondary Outcomes (1)

  • Plasma VEGF-C

    3 months (before, 4 weeks on, 2 weeks off and 4 weeks on medication)

Study Arms (2)

Patients

Metastatic cell carcinoma patients before sunitinib treatment, after 4 week on, after 2 week off and finally again 4 week on medication.

Drug: Sunitinib

Healthy controls

Age-matched subjects without known disease.

Interventions

SunitinibDRUG
Also known as: Diagnostic test: 23Na-MRI
Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe effect of the female hormonal cycle on skin sodium homeostasis is unknown, therefore we include here male subjects only.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic renal cell carcinome in the primary care of the Charité - Universitätsmedizin Berlin as well as healthy subjects without known disease recruited in the Charité - Universitätsmedizin Berlin and healthy volunteers form the Max-Delbrück Center of Molecular Medicine

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental and Clinical Research Center, Clinical Research Unit

Berlin, 13125, Germany

Location

Related Publications (4)

  • Kandula 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: 21900879BACKGROUND

  • Kappers 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: 20733093BACKGROUND

  • Machnik 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: 19412173BACKGROUND

  • Kopp 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: 23339169BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Hypertension

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dominik Müller, PhD

    Group leader at the Max Delbruck Center for Molecular Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 29, 2020

Study Start

November 1, 2015

Primary Completion

February 1, 2019

Study Completion

March 1, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)