NCT01950923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

2.5 years

First QC Date

September 24, 2013

Last Update Submit

July 2, 2018

Conditions

Kidney Tumor

Outcome Measures

Primary Outcomes (3)

  • Accrual rate

    Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.

    Up to 6 months

  • Retention rate

    Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.

    Up to 3 months

  • Participation rate

    Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.

    Up to 6 months

Secondary Outcomes (9)

  • Change in GFR

    Baseline to up to 1 month

  • Change in proteinuria

    Baseline to up to 3 months

  • Estimated blood loss

    At 24 hours after RPN

  • Hemoglobin concentration

    At 24 hours after RPN

  • Changes in blood pressure measurements

    Baseline to up to 2 days after RPN

  • +4 more secondary outcomes

Study Arms (2)

Arm I (sildenafil citrate)

EXPERIMENTAL

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

Drug: sildenafil citrateProcedure: therapeutic conventional surgery

Arm II (placebo)

PLACEBO COMPARATOR

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

Other: placeboProcedure: therapeutic conventional surgery

Interventions

sildenafil citrateDRUG

Given PO

Also known as: Viagra
Arm I (sildenafil citrate)
placeboOTHER

Given PO

Also known as: PLCB
Arm II (placebo)
therapeutic conventional surgeryPROCEDURE

Undergo standard robotic partial nephrectomy

Arm I (sildenafil citrate)Arm II (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ashok Hemal

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2013

First Posted

September 26, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 3, 2018

Record last verified: 2018-07

Locations

US(1)