NCT01950923

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Kidney Tumor

Interventions

Type	Name	Description
DRUG	sildenafil citrate	Given PO
OTHER	placebo	Given PO
PROCEDURE	therapeutic conventional surgery	Undergo standard robotic partial nephrectomy

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-09-26
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study