Evidence mapPaperPMID 31401795Full record

Trial reportJournal of nephrology2019

Improvement in wound healing, pain, and quality of life after 12 weeks of SNF472 treatment: a phase 2 open-label study of patients with calciphylaxis.

Vincent M Brandenburg, Smeeta Sinha, Jose-Vicente Torregrosa, Rekha Garg, Stephan Miller, Ana-Zeralda Canals, Daun Bahr, Pieter H Joubert, Carolina Salcedo, Kevin J Carroll and 2 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Vincent M BrandenburgDepartment of Cardiology, Nephrology, and Intensive Care Medicine, Rhein-Maas Klinikum, Mauerfeldchen 25, 52146, Würselen, Germany. Vincent.Brandenburg@post.rwth-aachen.de.
Smeeta SinhaSalford Royal NHS Foundation Trust, Salford, UK.
Jose-Vicente TorregrosaNephrology Department, Hospital Clinic, Barcelona, Spain.
Rekha GargSanifit Therapeutics, San Diego, CA, USA.
Stephan MillerSanifit Therapeutics, San Diego, CA, USA.
Ana-Zeralda CanalsSanifit Therapeutics, Palma, Spain.
Daun BahrSanifit Therapeutics, San Diego, CA, USA.
Pieter H JoubertKing's College, London, UK.
Carolina SalcedoSanifit Therapeutics, Palma, Spain.
Kevin J CarrollKJC Statistics, Cheshire, UK.
Alex GoldSanifit Therapeutics, San Diego, CA, USA.
Joan PerellóSanifit Therapeutics, Palma, Spain.
Sanifit (Spain) · ESCheshire West and Chester · GBHospital Clínic de Barcelona · ESKing's College London · GBKlinikum Rheine · DESalford Royal NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCalciphylaxis in end-stage renal disease is characterized by painful necrotic skin ulcers and high mortality. There are no approved therapies. SNF472, an intravenous formulation of myo-inositol hexaphosphate, inhibits the formation and growth of hydroxyapatite crystals, the final common pathway in the pathogenesis of vascular calcification.

methodsIn this open-label, single-arm study, calciphylaxis patients on thrice-weekly hemodialysis and standard care, received intravenous SNF472 3 times per week for 12 weeks. The primary endpoint was wound healing assessed using the quantitative Bates-Jensen Wound Assessment Tool (BWAT). Pain visual analog scale (VAS), quality of life (wound-QoL), and qualitative wound image review were secondary endpoints. Quantitative changes from baseline were analyzed by paired t-tests using multiple imputation to account for missing observations.

resultsFourteen patients received SNF472. Improvements from baseline to week 12 were observed for mean BWAT score (- 8.1; P < 0.001), pain VAS (- 23.6 mm; P = 0.015) and wound-QoL global score (- 0.90; P = 0.003). Of the 9 patients with ulcerated lesions at baseline who completed treatment, wound image review showed improvement for 7. SNF472 was well tolerated with no serious treatment-related adverse events. The most common adverse events were infections which occur frequently in patients on hemodialysis. None of these were considered as treatment-related.

conclusionsSNF472 was well-tolerated and improvements from baseline to week 12 in wound healing, pain, and quality of life were observed. A randomized, double-blind, placebo-controlled trial is planned to evaluate SNF472 in patients with calciphylaxis.

Indexed as

Quality of LifeAdultAgedAged, 80 and overCalciphylaxisFemaleHumansMaleMiddle AgedPainPhytic AcidProspective StudiesTime FactorsWound HealingPhytic AcidSNF472CalciphylaxisCUADialysismyo-inositol hexaphosphateSNF472

Identifiers

PMID31401795
OpenAlexW2968365993

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.