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  • 1
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    PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency
    SAGE Publications ; 2022
    In:  The Journal of Vascular Access Vol. 23, No. 2 ( 2022-03), p. 265-274
    Details
    In: The Journal of Vascular Access, SAGE Publications, Vol. 23, No. 2 ( 2022-03), p. 265-274
    Abstract: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency. Methods: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation. Of 696 screened, 613 were randomized, and 603 were treated (vonapanitase n = 405, placebo n = 208). The study drug solution was applied topically to the artery and vein for 10 min immediately after fistula creation. The primary endpoints were fistula use for hemodialysis and secondary patency (fistula survival without abandonment). Other efficacy endpoints included unassisted fistula use for hemodialysis, primary unassisted patency, fistula maturation and unassisted maturation by ultrasound criteria, and fistula procedure rates. Results: The proportions of patients with fistula use for hemodialysis was similar between groups, 70% vonapanitase and 65% placebo, ( p = 0.33). The Kaplan–Meier estimates of 12-month secondary patency were 78% (95% confidence interval [CI], 73–82) for vonapanitase and 76% (95% CI, 70–82) for placebo ( p = 0.93). The proportions with unassisted fistula use for hemodialysis were 46% vonapanitase and 37% placebo ( p = 0.054). The Kaplan–Meier estimates of 12-month primary unassisted patency were 50% (95% CI, 44–55) for vonapanitase and 43% (95% CI, 35–50) for placebo ( p = 0.18). There were no differences in the proportion of patients with fistula maturation or in fistula procedure rates. Adverse events were similar between groups. Vonapanitase was not immunogenic. Conclusions: Vonapanitase treatment did not achieve clinical or statistical significance to meaningfully improve radiocephalic fistula surgical outcomes. Outcome in the placebo group were better than in historical controls. Vonapanitase was well-tolerated and safe. TRIAL REGISTRATION: clinicaltrials.gov: NCT02414841 ( https://clinicaltrials.gov/ct2/show/NCT02414841 )
    Type of Medium: Online Resource
    ISSN: 1129-7298 , 1724-6032
    URL: Article
    DOI: 10.1177/1129729820985626
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2079292-X
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  • 2
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    A Multi-center, Dose-escalation Study of Human type I Pancreatic Elastase (PRT-201) Administered after Arteriovenous Fistula Creation
    SAGE Publications ; 2013
    In:  The Journal of Vascular Access Vol. 14, No. 2 ( 2013-04), p. 143-151
    Details
    In: The Journal of Vascular Access, SAGE Publications, Vol. 14, No. 2 ( 2013-04), p. 143-151
    Abstract: To explore the safety and efficacy of PRT-201. Methods Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.0033 to 9 mg) applied after arteriovenous fistula (AVF) creation. Participants were followed for one year. The primary outcome measure was safety. Efficacy measures were the proportion with intra-operative increases in AVF outflow vein diameter or blood flow ≥25% (primary), changes in outflow vein diameter and blood flow, AVF maturation and lumen stenosis by ultrasound criteria and AVF patency. Results The adverse events in the PRT-201 group (n=45) were similar to those in the placebo group (n=21). There were no differences in the proportion with ≥25% increase in vein diameter or blood flow, successful maturation or lumen stenosis. There was no statistically significant difference in primary patency between the dose groups (placebo n=21, Low Dose n=16, Medium Dose n=17 and High Dose n=12). In a subgroup analysis that excluded three participants with early surgical failures, the hazard ratio (HR) for primary patency loss of Low Dose compared with placebo was 0.38 (95% CI 0.10-1.41, P=0.15). In a Cox model, Low Dose (HR 0.27, 95% CI 0.04-0.79, P=0.09), white race (HR 0.17, 95% CI 0.03-0.79, P=0.02), and age 〈 65 years (HR 0.25, CI 0.05-1.15, P=0.08) were associated (P 〈 0.10) with a decreased risk of primary patency loss. Conclusions PRT-201 was not different from placebo for safety or efficacy measures. There was a suggestion for improved AVF primary patency with Low Dose PRT-201 that is now being studied in a larger clinical trial.
    Type of Medium: Online Resource
    ISSN: 1129-7298 , 1724-6032
    URL: Article
    DOI: 10.5301/jva.5000125
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2013
    detail.hit.zdb_id: 2079292-X
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  • 3
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    Application of Human Type I Pancreatic Elastase (PRT-201) to the venous Anastomosis of Arteriovenous Grafts in Patients with Chronic Kidney Disease
    SAGE Publications ; 2014
    In:  The Journal of Vascular Access Vol. 15, No. 5 ( 2014-09), p. 376-384
    Details
    In: The Journal of Vascular Access, SAGE Publications, Vol. 15, No. 5 ( 2014-09), p. 376-384
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1129-7298 , 1724-6032
    URL: Article
    DOI: 10.5301/jva.5000235
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
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  • 4
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    Effect of Colesevelam on Lovastatin Pharmacokinetics
    SAGE Publications ; 2002
    In:  Annals of Pharmacotherapy Vol. 36, No. 3 ( 2002-03), p. 392-397
    Details
    In: Annals of Pharmacotherapy, SAGE Publications, Vol. 36, No. 3 ( 2002-03), p. 392-397
    Abstract: To assess potential interactions of colesevelam hydrochloride and lovastatin in healthy volunteers when lovastatin alone was administered with dinner, both lovastatin and colesevelam were administered with dinner, and colesevelam was administered with dinner and lovastatin was administered 4 hours later with a snack. METHODS: A single-center, open-label, 3-period, crossover drug interaction study was performed with 22 healthy volunteers. Blood samples were collected at specified intervals before and after dosing, and plasma concentrations of lovastatin and lovastatin hydroxyacid were measured using a liquid chromatography/mass spectroscopy/mass spectroscopy method. RESULTS: Maximal concentration (C max ), AUC from time 0 to the last time point measured (AUC 0-t ), and AUC 0-∞ values for lovastatin were 102%, 94%, and 104%, and for lovastatin hydroxyacid were 102%, 91%, and 92%, respectively, of control values when colesevelam and lovastatin were coadministered with dinner. Administration of colesevelam with dinner and lovastatin 4 hours later with a snack resulted in a decreased C max and AUC 0-t for lovastatin (63% and 37%, respectively; p 〈 0.05) and an increased C max and AUC 0-t for lovastatin hydroxyacid (61% and 50%, respectively; p 〈 0.05), both compared with lovastatin alone administered with dinner. CONCLUSIONS: Colesevelam had no significant effect on lovastatin pharmacokinetics when coadministered with lovastatin at dinner. A split-dosing regimen resulted in alterations in pharmacokinetic parameters for lovastatin and lovastatin hydroxyacid that are likely due to known differences in the pharmacokinetics of lovastatin when administered to patients with meals or in a fasting state.
    Type of Medium: Online Resource
    ISSN: 1060-0280 , 1542-6270
    URL: Article
    DOI: 10.1345/aph.1A144
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2002
    detail.hit.zdb_id: 2053518-1
    SSG: 15,3
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  • 5
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    Absorption of Colesevelam Hydrochloride in Healthy Volunteers
    SAGE Publications ; 2002
    In:  Annals of Pharmacotherapy Vol. 36, No. 3 ( 2002-03), p. 398-403
    Details
    In: Annals of Pharmacotherapy, SAGE Publications, Vol. 36, No. 3 ( 2002-03), p. 398-403
    Abstract: To assess whether colesevelam hydrochloride is absorbed in healthy volunteers. METHODS: A single-center, open-label, radiolabeled study was performed with 16 healthy volunteers. Subjects were administered non-radiolabeled colesevelam hydrochloride 1.9 g twice daily for 4 weeks, followed by a single dose of [ 14 C]-colesevelam 2.4 g (480 μCi). These subjects continued to receive non-radioactive colesevelam 1.9 g twice daily for 4 days after administration of the radiolabeled dose. Blood, urine, and feces were collected immediately prior to administration of [ 14 C]-colesevelam and at specified intervals after administration. The whole-blood equivalent concentration of coleseve lam was calculated using data collected throughout the 96 hours following radiolabeled drug administration. The proportion of [ 14 C]-colesevelam excreted through urine or feces was calculated based on the amount of radioactivity recovered up to 216 hours after the radiolabeled dose. RESULTS: The mean cumulative total recovery of [ 14 C]-colesevelam in urine and feces was 0.05% and 74%, respectively. Excluding 2 subjects for whom cumulative recovery was 〈 25%, the mean cumulative fecal recovery was 82%. The mean maximum whole-blood equivalent concentration of colesevelam was 0.165 ± 0.10 μg equiv/g 72 hours after administration of [ 14 C]-colesevelam, which was estimated to be 0.04% of the administered dose. All blood samples contained 〈 4 × the number of background counts (dpm). CONCLUSIONS: The cumulative recovery data in urine and feces are consistent with the conclusion that colesevelam is not absorbed and is excreted entirely through the gastrointestinal system.
    Type of Medium: Online Resource
    ISSN: 1060-0280 , 1542-6270
    URL: Article
    DOI: 10.1345/aph.1A143
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2002
    detail.hit.zdb_id: 2053518-1
    SSG: 15,3
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  • 6
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    Frame Alignment Processes, Micromobilization, and Movement Participation
    SAGE Publications ; 1986
    In:  American Sociological Review Vol. 51, No. 4 ( 1986-08), p. 464-
    Details
    In: American Sociological Review, SAGE Publications, Vol. 51, No. 4 ( 1986-08), p. 464-
    Type of Medium: Online Resource
    ISSN: 0003-1224
    URL: Article
    DOI: 10.2307/2095581
    RVK:
    MN 1000
    Language: Unknown
    Publisher: SAGE Publications
    Publication Date: 1986
    detail.hit.zdb_id: 203405-0
    detail.hit.zdb_id: 2010058-9
    SSG: 2,1
    SSG: 3,4
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  • 7
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    Comparison of postoperative ultrasound criteria to predict unassisted use of arteriovenous fistulas for hemodialysis
    SAGE Publications ; 2018
    In:  The Journal of Vascular Access Vol. 19, No. 2 ( 2018-03), p. 167-171
    Details
    In: The Journal of Vascular Access, SAGE Publications, Vol. 19, No. 2 ( 2018-03), p. 167-171
    Abstract: Arteriovenous fistulas (AVF) frequently fail to mature. Postoperative ultrasounds provide objective measurements to predict unassisted AVF use for hemodialysis (unassisted use) and guide interventions to salvage nonmaturing AVFs. The optimal ultrasound criteria to assess AVF maturation are uncertain. We analyzed data from a multicenter, randomized, controlled, clinical trial to compare 2 published ultrasound maturation criteria used to predict unassisted AVF use for hemodialysis. Methods: We retrospectively analyzed prospective data on 105 patients undergoing new AVF creation, who underwent standardized postoperative ultrasounds at 6 and 12 weeks to measure AVF diameter and blood flow. Unassisted AVF use was defined as successful cannulation for ≥90 days without requiring prior surgical or percutaneous interventions. Two ultrasound criteria were assessed: (i) National Kidney Foundation (NKF) Kidney Disease Outcome Quality Initiative criteria: AVF outflow vein lumen diameter ≥6 mm and blood flow ≥600 mL/min; and (ii) University of Alabama at Birmingham (UAB) criteria: AVF outflow vein lumen diameter ≥4 mm and blood flow ≥500 mL/min. Performance characteristics were calculated for both criteria. Results: Compared to the NKF criteria, the UAB criteria had a higher sensitivity (89 vs.68%), but a lower specificity (42 vs. 70%) for unassisted AVF use. For radiocephalic AVFs, the UAB criteria had higher sensitivity (86 vs. 46%) and lower specificity (58 vs. 83%). For brachiocephalic AVFs, both UAB and NKF had high sensitivity (90 and 80%) but low specificity (21 and 53%), respectively. Conclusions: Using the UAB ultrasound criteria would minimize unnecessary early interventions in AVFs likely to mature without an intervention, but would delay interventions in AVFs that are unlikely to mature. The UAB criteria may be preferred in patients receiving a radiocephalic AVF.
    Type of Medium: Online Resource
    ISSN: 1129-7298 , 1724-6032
    URL: Article
    DOI: 10.5301/jva.5000818
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
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  • 8
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    Comparison of in Vivo Arteriovenous Fistula Volume Flow Measurements Using a Transonic Transit-Time Ultrasound Flow Device and Doppler Ultrasound
    SAGE Publications ; 2014
    In:  Journal for Vascular Ultrasound Vol. 38, No. 4 ( 2014-12), p. 187-197
    Details
    In: Journal for Vascular Ultrasound, SAGE Publications, Vol. 38, No. 4 ( 2014-12), p. 187-197
    Abstract: Doppler ultrasound (US) is extensively validated for classification of vascular disease based on velocity calculations. Although widely used to evaluate dialysis access arteriovenous fistulas (AVF), accurate volume flow measurements have proved more elusive, with significant variability resulting in large thresholds for differentiation of normally functioning from failing fistulae. We sought to compare in vivo measurements of AVF blood flow volume measured by the Transonic transit-time ultrasound flow device with those of Doppler US. Methods Bilateral femoral AVFs (n = 6) were created in swine (n = 3). Comparative volume flow measurements were made at baseline, 15, 30, 60, and 120 minutes after the creation of AVFs with the Transonic device and with Doppler US using an estimated time averaged velocity and the diameter of the vessel to calculate volume flow using the formula: Q = v A = v (π r 2 ), where Q = volume flow, v = time and spatial averaged mean velocity, A = cross-sectional area, and r = radius of the vessel. Repeat measurements (minimum 3) were performed at each time point. Linear and multiple linear regression analyses were performed. Results Linear regression analyses showed a weak correlation (R 2 = 0.103, p = 0.002) between Transonic and Doppler volume flow measurements. Doppler consistently showed greater volume flow over all time points than Transonic data. Average Transonic values had less variability over time (R 2 = 0.9505) compared with average Doppler measurements (R 2 = 0.7601). Average flow increased over time, regardless of the flow measurement device, consistent with reported clinical observation of AVF maturation process. Multiple linear regression analysis demonstrated correlation between Doppler and Transonic data (R 2 = 0.197, p = 0.013), and provided a formula to estimate Transonic flow measurement from the Doppler data. [Transonic = 113.742 + (0.334 * Doppler)]. Conclusions Transonic data demonstrated a stronger relationship between volume flow and time than Doppler data, suggesting transit time ultrasound volume flow measurements may be more accurate. Doppler data tended to overestimate volume flow measurements; however, it may be feasible to use a correction factor for Doppler data that predicts Transonic results.
    Type of Medium: Online Resource
    ISSN: 1544-3167 , 1544-3175
    URL: Article
    DOI: 10.1177/154431671403800401
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
    detail.hit.zdb_id: 2127200-1
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  • 9
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    Coping with global uncertainty: Perceptions of COVID-19 psychological distress, relationship quality, and dyadic coping for romantic partners across 27 countries
    SAGE Publications ; 2022
    In:  Journal of Social and Personal Relationships Vol. 39, No. 1 ( 2022-01), p. 3-33
    Details
    In: Journal of Social and Personal Relationships, SAGE Publications, Vol. 39, No. 1 ( 2022-01), p. 3-33
    Abstract: Following the global outbreak of COVID-19 in March 2020, individuals report psychological distress associated with the “new normal”—social distancing, financial hardships, and increased responsibilities while working from home. Given the interpersonal nature of stress and coping responses between romantic partners, based on the systemic transactional model this study posits that perceived partner dyadic coping may be an important moderator between experiences of COVID-19 psychological distress and relationship quality. To examine these associations, self-report data from 14,020 people across 27 countries were collected during the early phases of the COVID-19 pandemic (March–July, 2020). It was hypothesized that higher symptoms of psychological distress would be reported post-COVID-19 compared to pre-COVID-19 restrictions (Hypothesis 1), reports of post-COVID-19 psychological distress would be negatively associated with relationship quality (Hypothesis 2), and perceived partner DC would moderate these associations (Hypothesis 3). While hypotheses were generally supported, results also showed interesting between-country variability. Limitations and future directions are presented.
    Type of Medium: Online Resource
    ISSN: 0265-4075 , 1460-3608
    URL: Article
    DOI: 10.1177/02654075211034236
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2023968-3
    SSG: 5,2
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