Kidney TumorPhase 1NCT01950923
Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer
A Phase 1 study testing sildenafil citrate and therapeutic conventional surgery in people with Kidney Tumor, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumor
- What is being tested?
- sildenafil citrate and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2016
- Phase
- Phase 1
- 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
Who may be able to join
- Patients who are scheduled to undergo robotic partial nephrectomy for suspected renal malignancy
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with a history of coronary artery disease (including history of myocardial infarction or cardiac stents) or a history of inducible ischemic changes on any prior cardiac stress testing
- History of adverse reactions to any phosphodiesterase (PDE) inhibitor (PDE type 5 inhibitor [PDE5i])
- Any patient currently taking a PDE5i will be asked to refrain from use for one week prior to their surgery; patients who have used a PDE5i within 72 hours of surgery will be excluded
- Pregnant women are excluded from this study
- Patients with only one kidney
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study
This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (RPN) for a suspected renal malignancy.
SECONDARY OBJECTIVES:
- To evaluate individual alterations in glomerular filtration rate (GFR) at 24 hours, 48 hours and one month following RPN and compare these to the placebo group.
II. To evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following RPN and compare these to the placebo group.
III. To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN.
IV. To describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit.
- To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure.
VI. To compare overall complication rates (within 90 days postoperatively) between groups.
VII. To obtain a preliminary effect size of sildenafil on change in GFR at three months following RPN.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sildenafil citrate orally (PO) before the initiation of standard robotic partial nephrectomy.
ARM II: Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.
After completion of study treatment, patients are followed up at 1 and 3 months.
- Conditions
- Kidney Tumor
- Being tested
- sildenafil citrate, placebo, therapeutic conventional surgery
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil citrateDrug
Also called Viagra
Given PO
placeboOther
Also called PLCB
Given PO
therapeutic conventional surgeryProcedure or surgery
Undergo standard robotic partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (sildenafil citrate) | Experimental | Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy. Receives: Drug: sildenafil citrate; Procedure: therapeutic conventional surgery |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO before the initiation of standard robotic partial nephrectomy. Receives: Other: placebo; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate
Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
Measured: Up to 6 months
Retention rate
Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.
Measured: Up to 3 months
Participation rate
Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
Measured: Up to 6 months
Secondary outcomes (9)
Change in GFR
Regression analysis will be used; the change will be modeled, with adjustment for baseline GFR, to assess difference in the two study groups.
Measured: Baseline to up to 1 month
Change in proteinuria
Compared between the two study groups.
Measured: Baseline to up to 3 months
Estimated blood loss
Compared between the two study groups.
Measured: At 24 hours after RPN
Hemoglobin concentration
Compared between the two study groups.
Measured: At 24 hours after RPN
Changes in blood pressure measurements
Compared between the two study groups.
Measured: Baseline to up to 2 days after RPN
Vasopressor support requirements during the operative procedure
Compared between the two study groups.
Measured: During RPN
Intravenous fluid requirements during the operative procedure
Compared between the two study groups.
Measured: During RPN
Overall complication rates
Compared between the two study groups.
Measured: Up to 90 days after RPN
Preliminary effect size of sildenafil citrate on change in GFR
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TumorStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ashok Hemal, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950923
- Sponsor's protocol ID
- IRB00021729-1
- Other IDs
- NCI-2013-00988, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 24 Sep 2013
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01950923
- Acronym / sponsor ID
- IRB00021729-1
- Conditions
- Kidney Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Sep 2013 (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.
This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.
Detailed description
PRIMARY OBJECTIVES:
- To assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (RPN) for a suspected renal malignancy.
SECONDARY OBJECTIVES:
- To evaluate individual alterations in glomerular filtration rate (GFR) at 24 hours, 48 hours and one month following RPN and compare these to the placebo group.
II. To evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following RPN and compare these to the placebo group.
III. To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN.
IV. To describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit.
- To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure.
VI. To compare overall complication rates (within 90 days postoperatively) between groups.
VII. To obtain a preliminary effect size of sildenafil on change in GFR at three months following RPN.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sildenafil citrate orally (PO) before the initiation of standard robotic partial nephrectomy.
ARM II: Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.
After completion of study treatment, patients are followed up at 1 and 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (sildenafil citrate) | Experimental | Drug: sildenafil citrate, Procedure: therapeutic conventional surgeryPatients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Procedure: therapeutic conventional surgeryPatients receive placebo PO before the initiation of standard robotic partial nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled to undergo robotic partial nephrectomy for suspected renal malignancy
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (5 listed)
- Patients with a history of coronary artery disease (including history of myocardial infarction or cardiac stents) or a history of inducible ischemic changes on any prior cardiac stress testing
- History of adverse reactions to any phosphodiesterase (PDE) inhibitor (PDE type 5 inhibitor [PDE5i])
- Any patient currently taking a PDE5i will be asked to refrain from use for one week prior to their surgery; patients who have used a PDE5i within 72 hours of surgery will be excluded
- Pregnant women are excluded from this study
- Patients with only one kidney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafil citrateAlso: ViagraGiven PO | Drug | Arm I (sildenafil citrate) |
| placeboAlso: PLCBGiven PO | Other | Arm II (placebo) |
| therapeutic conventional surgeryUndergo standard robotic partial nephrectomy | Procedure or surgery | Arm I (sildenafil citrate), Arm II (placebo) |
Primary outcome
Accrual rate
Time frame: Up to 6 months
Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
Retention rate
Time frame: Up to 3 months
Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.
Participation rate
Time frame: Up to 6 months
Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
9 secondary outcomes
Change in GFR
Time frame: Baseline to up to 1 month
Change in proteinuria
Time frame: Baseline to up to 3 months
Estimated blood loss
Time frame: At 24 hours after RPN
Hemoglobin concentration
Time frame: At 24 hours after RPN
Changes in blood pressure measurements
Time frame: Baseline to up to 2 days after RPN
Vasopressor support requirements during the operative procedure
Time frame: During RPN
Intravenous fluid requirements during the operative procedure
Time frame: During RPN
Overall complication rates
Time frame: Up to 90 days after RPN
Preliminary effect size of sildenafil citrate on change in GFR
Time frame: At 3 months
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 3 Jul 2018.
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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.
Ashok Hemal principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sildenafil citrate and therapeutic conventional surgery in people with Kidney Tumor, run by Wake Forest University Health Sciences at 1 site in United States.
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 2 inclusion and 5 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 3 Jul 2018. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accrual rate (time frame: Up to 6 months). 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?
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 3 Jul 2018.