HypertensionNCT01227213
The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
An observational study of Hypertension and Renal Function, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Renal Function, Insulin Sensitivity
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with metastatic renal cell carcinoma starting treatment with sunitinib
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form
- Age 18 years or older
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- mRCC patients in which the treatment of choice is sunitinib
Who cannot join
- Use of corticosteroids
- Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
- Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
- Patients being treated with oral anticoagulants if to be included in group A.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.
Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.
Read more
Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.
Study design: Single-centre non randomized observational study Study population: 30 Patients (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.
- Medical subject headings
- Hypertension, Insulin Resistance, Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Group A:
Vasomotor response to intra-arterially administered doses of acetylcholine and nitroprusside before and after start sunitinib
Measured: 2 weeks
Insulin sensitivity
Group B:
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start sunitinib
Measured: 2 weeks
GFR and renal perfusion flow
Group C:
GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib
Measured: 2 weeks
Secondary outcomes (3)
Blood pressure
Measured: 3 months
Weight
Measured: 3 months
Laboratory evaluations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, G. Rongen, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227213
- Sponsor's protocol ID
- SUMAVA
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2010
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thijs AM, van Herpen CM, Verweij V, Pertijs J, van den Broek PH, van der Graaf WT, Rongen GA. Impaired endothelium-dependent vasodilation does not initiate the development of sunitinib-associated hypertension. J Hypertens. 2015 Oct;33(10):2075-82. doi: 10.1097/HJH.0000000000000662.
PubMed 26203967Thijs AM, Tack CJ, van der Graaf WT, Rongen GA, van Herpen CM. The early effect of sunitinib on insulin clearance in patients with metastatic renal cell carcinoma. Br J Clin Pharmacol. 2016 Apr;81(4):768-72. doi: 10.1111/bcp.12797. Epub 2016 Jan 14.
PubMed 26447463
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01227213
- Acronym / sponsor ID
- SUMAVA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.
Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.
Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.
Study design: Single-centre non randomized observational study Study population: 30 Patients (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with metastatic renal cell carcinoma starting treatment with sunitinib
Key inclusion criteria (5 listed)
- Subject is able and willing to sign the Informed Consent Form
- Age 18 years or older
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- mRCC patients in which the treatment of choice is sunitinib
Key exclusion criteria (4 listed)
- Use of corticosteroids
- Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
- Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
- Patients being treated with oral anticoagulants if to be included in group A.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endothelial function
Time frame: 2 weeks
Group A: Vasomotor response to intra-arterially administered doses of acetylcholine and nitroprusside before and after start sunitinib
Insulin sensitivity
Time frame: 2 weeks
Group B: Insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start sunitinib
GFR and renal perfusion flow
Time frame: 2 weeks
Group C: GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib
3 secondary outcomes
Blood pressure
Time frame: 3 months
Weight
Time frame: 3 months
Laboratory evaluations
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Results publication: PubMed 26203967Thijs AM, van Herpen CM, Verweij V, Pertijs J, van den Broek PH, van der Graaf WT, Rongen GA. Impaired endothelium-dependent vasodilation does not initiate the development of sunitinib-associated hypertension. J Hypertens. 2015 Oct;33(10):2075-82. doi: 10.1097/HJH.0000000000000662.
- Results publication: PubMed 26447463Thijs AM, Tack CJ, van der Graaf WT, Rongen GA, van Herpen CM. The early effect of sunitinib on insulin clearance in patients with metastatic renal cell carcinoma. Br J Clin Pharmacol. 2016 Apr;81(4):768-72. doi: 10.1111/bcp.12797. Epub 2016 Jan 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Renal Function, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.