PDE5i Use in Renal Transplant Recipients

NCT04122105 | Withdrawn

• 1 other identifier: (H19-02487)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Failure

Outcome Measures

Primary Outcomes (1)

• renal transplant function within 90 days postop

  renal functional improvement

  90 days postop

Secondary Outcomes (1)

• perioperative safety of sildenafil administration in renal transplantation

  intraoperative and 90 days postop

Study Arms (2)

intervention

EXPERIMENTAL

sildenafil administration perioperative to renal transplant

Drug: Sildenafil

control

ACTIVE COMPARATOR

renal transplant recipients

Drug: Sildenafil

Interventions

Sildenafil DRUG

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.

control; intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V6N2A2, Canada

Location

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: April 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)