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

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

Conditions: Kidney Tumor

Treatments: Procedure: therapeutic conventional surgery; Other: placebo; Drug: sildenafil citrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01950923

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2013-00988 (Registry Identifier)

IRB00021729-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Arm I (sildenafil citrate)

Experimental group

Description:

Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy.

Treatment:

Drug: sildenafil citrate

Procedure: therapeutic conventional surgery

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.

Treatment:

Procedure: therapeutic conventional surgery

Other: placebo