SP581VONAPANITASE PIVOTAL TRIAL TO INCREASES FISTULA USE FOR HEMODIALYSIS AND SECONDARY PATENCY
Bibliographic record
Abstract
INTRODUCTION: Vonapanitase, an investigational recombinant human chymotrypsin-like elastase family member 1 (CELA1), is applied intra-operatively for 10 minutes to the external surface of a fistula immediately after surgical creation. In previous clinical trials, vonapanitase was associated with increased fistula use for hemodialysis and secondary patency (Bleyer 2018). METHODS: The PATENCY-2 trial, a “Multicenter, Double-Blind, Placebo-controlled Study of Vonapanitase (PRT-201) Administered Immediately after Radiocephalic Fistula Creation in Patients with Chronic Kidney Disease” is being conducted at 39 centers in the US and Canada to assess the safety and efficacy of vonapanitase (NCT02414841). Key inclusion criteria included age ≥18, diagnosis of chronic kidney disease, and planned creation of a radiocephalic fistula. A total of 613 patients were enrolled and 603 treated with vonapanitase or placebo in a 2:1 randomization stratified by hemodialysis status. Patients are followed for 12 months. The co-primary endpoints are use for 2-needle hemodialysis (≥90 days of use or ≥30 days of use and in use at the final study visit) and secondary patency (survival of the fistula without abandonment). Additional endpoints are unassisted fistula use, primary patency, maturation by ultrasound, and rate of procedures to the fistula. Patients whose fistulas are not abandoned enter a registry for an additional 2 years of follow-up. RESULTS: The last patient enrolled was treated in March 2018. Baseline characteristics were: white/black/other 68%, 24%, 8%; male/female 76%, 24%; age 57±13 years; BMI 32±8; kidney disease due to diabetes/hypertension/other 46%, 24%, 30%; and on hemodialysis yes/no 45%, 55%. Preexisting conditions included congestive heart failure 28% and ischemic heart disease 36%. The fistula was placed in the left arm in 76% and at the wrist, forearm, and snuffbox in 71%, 25%, and 3%. Anesthesia employed was local, regional, general, and other in 50%, 35%, 21%, 9%. CONCLUSIONS: Top-line results will be available in March 2019 and final data and conclusions will be presented at the meeting.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".