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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Tumor
• Intervention / Treatment: Other: placebo; Drug: sildenafil citrate; Procedure: therapeutic conventional surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (sildenafil citrate); Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy.	Drug: sildenafil citrate; Given PO; Other Names: Viagra; Procedure: therapeutic conventional surgery; Undergo standard robotic partial nephrectomy
Placebo Comparator: Arm II (placebo); Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.	Other: placebo; Given PO; Other Names: PLCB; Procedure: therapeutic conventional surgery; Undergo standard robotic partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in proteinuria	Compared between the two study groups.	Baseline to up to 3 months
Estimated blood loss	Compared between the two study groups.	At 24 hours after RPN
Hemoglobin concentration	Compared between the two study groups.	At 24 hours after RPN
Changes in blood pressure measurements	Compared between the two study groups.	Baseline to up to 2 days after RPN
Vasopressor support requirements during the operative procedure	Compared between the two study groups.	During RPN
Intravenous fluid requirements during the operative procedure	Compared between the two study groups.	During RPN
Overall complication rates	Compared between the two study groups.	Up to 90 days after RPN
Preliminary effect size of sildenafil citrate on change in GFR		At 3 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ashok Hemal, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: IRB00021729-1; P30CA012197 (U.S. NIH Grant/Contract); NCI-2013-00988 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No