N/A
Completed N=4
Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula
Improve Endothelial Function and Decrease Vascular Stenosis
Source: ClinicalTrials.gov NCT02414204 ↗
Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group — 10.8; 8.6 Change in FMD%
Summary
Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited from the UAB Vascular Access Clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group |
10.8; 8.6 | — |
| SECONDARY Number of Participants With a Change in Blood Flow Rate |
2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥19 years of age male or female
- Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery
Exclusion Criteria
- Patient currently on nitrate therapy or any nitric oxide donor in any form
- Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor
- Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure < 50 mm Hg.
- Patient life expectancy < nine months.
- Patient unable or unwilling to meet study requirements.
Data sourced from ClinicalTrials.gov (NCT02414204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.