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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 21, 2014
Last verified: July 2014
  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
Kidney Tumor
Drug: sildenafil citrate
Other: placebo
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950923

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ashok Hemal    336-716-5694    ahemal@wakehealth.edu   
Principal Investigator: Ashok Hemal         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Ashok Hemal Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01950923     History of Changes
Other Study ID Numbers: CCCWFU 99612, NCI-2013-00988, P30CA012197
Study First Received: September 24, 2013
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Neoplasms
Kidney Diseases
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Citric Acid
Sildenafil
Anticoagulants
Cardiovascular Agents
Chelating Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Sequestering Agents
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014