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

This study is currently recruiting participants.
Verified September 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01950923
First received: September 24, 2013
Last updated: September 25, 2013
Last verified: September 2013

September 24, 2013
September 25, 2013
September 2013
September 2016   (final data collection date for primary outcome measure)
  • Accrual rate [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
Same as current
Complete list of historical versions of study NCT01950923 on ClinicalTrials.gov Archive Site
  • Change in GFR [ Time Frame: Baseline to up to 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Estimated blood loss [ Time Frame: At 24 hours after RPN ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Hemoglobin concentration [ Time Frame: At 24 hours after RPN ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Changes in blood pressure measurements [ Time Frame: Baseline to up to 2 days after RPN ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Vasopressor support requirements during the operative procedure [ Time Frame: During RPN ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Intravenous fluid requirements during the operative procedure [ Time Frame: During RPN ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Overall complication rates [ Time Frame: Up to 90 days after RPN ] [ Designated as safety issue: No ]
    Compared between the two study groups.
  • Preliminary effect size of sildenafil citrate on change in GFR [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Kidney Tumor
  • Drug: sildenafil citrate
    Given PO
    Other Name: Viagra
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Procedure: therapeutic conventional surgery
    Undergo standard robotic partial nephrectomy
  • Experimental: Arm I (sildenafil citrate)
    Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy.
    Interventions:
    • Drug: sildenafil citrate
    • Procedure: therapeutic conventional surgery
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.
    Interventions:
    • Other: placebo
    • Procedure: therapeutic conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01950923
CCCWFU 99612, NCI-2013-00988, P30CA012197
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Ashok Hemal Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP