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PDE5i Use in Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT04122105
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher Nguan, University of British Columbia

Brief Summary:
Ischemia-reperfusion (IRI) injuries are common in renal transplantation and cause poor patient outcomes. Ischemia occurs after the donor's death and reperfusion occurs after kidney implantation. The donor kidney undergoes warm ischemia (WIT) after blood circulation stops and cold ischemia (CIT) when subjected to cold storage during transportation. Decreased blood flow leads to waste product accumulation and cellular damage. During reperfusion, reactive oxygen radicals and inflammatory processes further damage the kidney. PDE5 inhibitors increase renal blood flow and could protect the kidney during transplantation. Our study assesses the utility of giving these drugs perioperatively to reduce the effects of IRI injury.

Condition or disease Intervention/treatment Phase
Renal Transplant Failure Drug: Sildenafil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: PDE5i Use in Renal Transplant Recipients
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention
sildenafil administration perioperative to renal transplant
Drug: Sildenafil
The intervention group will receive standard care in all capacities with the exception of sildenafil administration. The first dose (50mg) will be given 1-hour prior to the surgery. Patients will be given Sildenafil twice daily up to 3 days post-transplant.

Active Comparator: control
renal transplant recipients
Drug: Sildenafil
The intervention group will receive standard care in all capacities with the exception of sildenafil administration. The first dose (50mg) will be given 1-hour prior to the surgery. Patients will be given Sildenafil twice daily up to 3 days post-transplant.




Primary Outcome Measures :
  1. renal transplant function within 90 days postop [ Time Frame: 90 days postop ]
    renal functional improvement


Secondary Outcome Measures :
  1. perioperative safety of sildenafil administration in renal transplantation [ Time Frame: intraoperative and 90 days postop ]
    perioperative safety of sildenafil administration to renal transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • renal transplant patients at VGH undergoing donation after circulatory death (DCD) and donation after brain death (DBD) kidney transplants
  • 19 years of age
  • able to provide consent.

Exclusion Criteria:

  • Patients that are unable to understand the purpose of the study or cannot give written consent will be excluded.
  • Moreover, patients with contraindications to PDE5 inhibitors will be excluded from the study. PDE5 inhibitors are generally well tolerated, even in patients with severe renal disease, those on dialysis, and in transplant recipients. Patients will be excluded if they are taking nitrates of any form (contraindication), are allergic to sildenafil or any of the ingredients of this medication, are on an alpha-adrenergic blocker (potential risk)
  • patients currently on any experimental drug in the last 3 months (confounding factor).

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): NCT04122105


Locations
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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V6N2A2
Sponsors and Collaborators
University of British Columbia
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Responsible Party: Christopher Nguan, associate professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04122105    
Other Study ID Numbers: (H19-02487)
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents