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

Kidney Tumor research study

What is the primary objective of this 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Kidney Tumor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:sildenafil citrateGiven PO

Other:placeboGiven PO

Procedure:therapeutic conventional surgeryUndergo standard robotic partial nephrectomy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm I (sildenafil citrate)Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy.

Arm II (placebo)Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.

Study Status

Completed

Start Date: September 2013

Completed Date: March 2016

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Accrual rate

Secondary Outcome: Change in GFR

Study sponsors, principal investigator, and references

Principal Investigator: Ashok Hemal

Lead Sponsor: Wake Forest University Health Sciences

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01950923

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