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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01950923
First Posted: September 26, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention Phase
Kidney Tumor Drug: sildenafil citrate Other: placebo Procedure: therapeutic conventional surgery Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Accrual rate [ Time Frame: Up to 6 months ]
    Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.

  • Retention rate [ Time Frame: Up to 3 months ]
    Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.

  • Participation rate [ Time Frame: Up to 6 months ]
    Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.


Secondary Outcome Measures:
  • Change in GFR [ Time Frame: Baseline to up to 1 month ]
    Regression analysis will be used; the change will be modeled, with adjustment for baseline GFR, to assess difference in the two study groups.

  • Change in proteinuria [ Time Frame: Baseline to up to 3 months ]
    Compared between the two study groups.

  • Estimated blood loss [ Time Frame: At 24 hours after RPN ]
    Compared between the two study groups.

  • Hemoglobin concentration [ Time Frame: At 24 hours after RPN ]
    Compared between the two study groups.

  • Changes in blood pressure measurements [ Time Frame: Baseline to up to 2 days after RPN ]
    Compared between the two study groups.

  • Vasopressor support requirements during the operative procedure [ Time Frame: During RPN ]
    Compared between the two study groups.

  • Intravenous fluid requirements during the operative procedure [ Time Frame: During RPN ]
    Compared between the two study groups.

  • Overall complication rates [ Time Frame: Up to 90 days after RPN ]
    Compared between the two study groups.

  • Preliminary effect size of sildenafil citrate on change in GFR [ Time Frame: At 3 months ]

Enrollment: 30
Study Start Date: September 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (sildenafil citrate)
Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy.
Drug: sildenafil citrate
Given PO
Other Name: 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 Name: PLCB
Procedure: therapeutic conventional surgery
Undergo standard robotic partial nephrectomy

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950923


Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ashok Hemal Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01950923     History of Changes
Other Study ID Numbers: CCCWFU 99612
NCI-2013-00988 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2013
First Posted: September 26, 2013
Last Update Posted: May 30, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents