Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer

Kidney Tumor Clinical Trial

Official title:

Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950923
• Other study ID #: IRB00021729-1
• Secondary ID: NCI-2013-00988P3
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Kidney Tumor

Intervention

Drug:
• sildenafil citrate
Given PO

Other:
• placebo
Given PO

Procedure:
• therapeutic conventional surgery
Undergo standard robotic partial nephrectomy

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Primary	Retention rate	Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.	Up to 3 months
Primary	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.	Up to 6 months
Secondary	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.	Baseline to up to 1 month
Secondary	Change in proteinuria	Compared between the two study groups.	Baseline to up to 3 months
Secondary	Estimated blood loss	Compared between the two study groups.	At 24 hours after RPN
Secondary	Hemoglobin concentration	Compared between the two study groups.	At 24 hours after RPN
Secondary	Changes in blood pressure measurements	Compared between the two study groups.	Baseline to up to 2 days after RPN
Secondary	Vasopressor support requirements during the operative procedure	Compared between the two study groups.	During RPN
Secondary	Intravenous fluid requirements during the operative procedure	Compared between the two study groups.	During RPN
Secondary	Overall complication rates	Compared between the two study groups.	Up to 90 days after RPN
Secondary	Preliminary effect size of sildenafil citrate on change in GFR		At 3 months