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

NCT ID: NCT01950923

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (sildenafil citrate)

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

Group Type: EXPERIMENTAL

sildenafil citrate

Intervention Type: DRUG

Given PO

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo standard robotic partial nephrectomy

Arm II (placebo)

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given PO

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo standard robotic partial nephrectomy

Interventions

sildenafil citrate

Given PO

Intervention Type: DRUG

placebo

Given PO

Intervention Type: OTHER

therapeutic conventional surgery

Undergo standard robotic partial nephrectomy

Intervention Type: PROCEDURE

Other Intervention Names

Viagra; PLCB

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashok Hemal

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2013-00988

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00021729-1

Identifier Type: -

Identifier Source: org_study_id