We studied the impact of a first post-transplant cytomegalovirus (CMV) infection greater than one year after primary kidney transplantation. Risk factors for developing late CMV were acute rejection and donor–recipient CMV status. Of those developing late CMV, 35% were donor (D) positive, recipient (R) negative; however, 23% were D+R+, 22% D−R+, and 15% D−R−. Late CMV was associated with significantly decreased patient and graft survival.
Nonadherence (NA) is a difficult posttransplant problem that can lead to graft loss. A retransplant for these recipients is controversial because of a fear of recurrent NA. We reviewed our center’s database and identified 119 recipients who lost their graft to overt NA; of this group, 38 (32%) underwent a retransplant after a thorough reevaluation. We compared this NA retransplant group to a control group of 2nd transplant recipients who did not lose their 1st graft to overt NA (n=728). After 8 years of follow-up, we found no differences between the 2 groups in actuarial graft or patient survival rates, renal function, or the incidence of biopsy-proven chronic rejection. However, 3 of 38 NA recipients vs. 9 of 728 2nd transplant recipients lost their retransplant to NA (p=0.03). We conclude that prior graft loss to NA is associated with increased graft loss to NA after retransplant; still, the majority of NA retransplant recipients did well – their overall long-term outcomes were similar to those of the 2nd transplant group. With careful patient selection and aggressive intervention, prior NA should not be an absolute contraindication to a retransplant.
The VWING was safe and effective in facilitating AVF cannulation for patients with an otherwise mature but noncannulatable fistula. Successful AVF access was achieved using the VWING in 49 (96%) of the 51 patients evaluated. The AVF survival rate at 6 months was 100%.
PRT-201 appeared safe. The primary efficacy end point was not met. However, both PRT-201 doses were associated with improved unassisted maturation. The 30-μg dose was associated with increased PP in the subset with RCF.
Purpose
To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft (AVG).
Methods
Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.01 to 9 mg) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement. The primary outcome measure was safety. The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate, primary unassisted patency, and secondary patency by dose groups (placebo, low, medium, high and All PRT-201).
Results
A total of 89 patients were treated (28 placebo and 61 PRT-201). There were no significant differences in the proportion of placebo and PRT-201 patients reporting adverse events. Intraoperative outflow vein diameter increased 5% (p=0.14) in the placebo group compared with 13% (p=0.01), 15% (p=0.07) and 12% (p<0.001), in the low, medium and high groups, respectively. The comparison between the high and placebo groups was marginally statistically significant (p=0.06). The intraoperative blood flow did not change in the placebo group, and increased in the low, medium and high groups by 19% (p=0.34), 36% (p=0.09) and 46% (p=0.02), respectively. The low group had the longest primary unassisted and secondary patency and the fewest procedures to restore or maintain patency; however, the differences between groups were not statistically significant.
Conclusions
PRT-201 was well tolerated and increased AVG intraoperative outflow vein diameter and blood flow. Low dose tended to increase secondary patency and decrease the rate of procedures to restore or maintain patency. Larger studies with these doses will be necessary to confirm these results.
Objective: Arteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis. Methods: PATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n ¼ 210) or placebo (n ¼ 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates. Results: The Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P ¼ .25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P ¼ .048). The proportions of vonapanitase and placebo patients were 39% and 25% (P ¼ .035) with unassisted use for hemodialysis and 64% and 44% (P ¼ .006) with unassisted plus assisted use. Conclusions: Vonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.
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