Evidence map›Paper›PMID 30783888›Full record

ArticleInternational urology and nephrology2019

ALLN-177, oral enzyme therapy for hyperoxaluria.

James E Lingeman, Gyan Pareek, Linda Easter, Rita Pease, Danica Grujic, Lee Brettman, Craig B Langman

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in International urology and nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.2field-weighted citation impact, top 5% 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.

NCT02289755 phase2completednot on this map

A Phase 2 Multicenter, Open Label, Single Arm Study Evaluating the Effect of ALLN-177 to Reduce Urinary Oxalate Excretion in Recurrent Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

TypeinterventionalSponsorAllena PharmaceuticalsRan2014 to 2015Enrolled16ConditionsHyperoxaluria, NephrolithiasisArmsALLN-177
NCT03847090 phase3terminatednot on this map

Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)

TypeinterventionalSponsorAllena PharmaceuticalsRan2019 to 2022Enrolled92ConditionsEnteric HyperoxaluriaArmsReloxaliase, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 39 citations in OpenAlex.

  1. Review
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  7. Infant primary hyperoxaluria type 1Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  8. Review
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  12. Oxalate homeostasis.Nature reviews. Nephrology · 2023
    Review
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  17. Subsequent urinary stone events are predicted by the magnitude of urinary oxalate excretion in enteric hyperoxaluria.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
    Article
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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

7 authors at 4 institutions in 1 country.

James E LingemanDepartment of Urology, Indiana University School of Medicine, 1801 N Senate Blvd #220, Indianapolis, IN, 46202, USA.
Gyan PareekDivision of Urology, The Warren Alpert Medical School of Brown University, 2 Dudley Street Suite 174, Providence, RI, 02905, USA.
Linda EasterClinical and Translational Science Institute, Wake Forest University School of Medicine, 1st Floor, Meads Hall, 1 Medical Center Boulevard, Winston-Salem, NC, 27106, USA.
Rita PeaseAllena Pharmaceuticals, One Newton Executive Park, Suite 202, Newton, MA, 02462, USA.
Danica GrujicAllena Pharmaceuticals, One Newton Executive Park, Suite 202, Newton, MA, 02462, USA.
Lee BrettmanAllena Pharmaceuticals, One Newton Executive Park, Suite 202, Newton, MA, 02462, USA.
Craig B LangmanFeinberg School of Medicine, Northwestern University, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Avenue, Chicago, IL, 60611, USA. c-langman@northwestern.edu.ORCID http://orcid.org/0000-0002-8223-9220
Brown University · USIndiana University School of MedicineNorthwestern University · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the potential of ALLN-177, an orally administered, oxalate-specific enzyme therapy to reduce urine oxalate (UOx) excretion in patients with secondary hyperoxaluria.

methodsSixteen male and female subjects with both hyperoxaluria and a kidney stone history were enrolled in an open-label study. Subjects continued their usual diets and therapies. During a 3-day baseline period, two 24-h (24-h) urines were collected, followed by a 4-day treatment period with ALLN-177 (7,500 units/meal, 3 × day) when three 24-h urines were collected. The primary endpoint was the change in mean 24-h UOx from baseline. Safety assessments and 24-h dietary recalls were performed throughout.

resultsThe study enrolled 5 subjects with enteric hyperoxaluria and 11 with idiopathic hyperoxaluria. ALLN-177 was well tolerated. Overall mean (SD) UOx decreased from 77.7 (55.9) at baseline to 63.7 (40.1) mg/24 h while on ALLN-177 therapy, with the mean reduction of 14 mg/24 h, (95% CI - 23.71, - 4.13). The calcium oxalate-relative urinary supersaturation ratio in the overall population decreased from a mean of 11.3 (5.7) to 8.8 (3.8) (- 2.8; 95% CI - 4.9, - 0.79). This difference was driven by oxalate reduction alone, but not any other urinary parameters. Mean daily dietary oxalate, calcium, and fluid intake recorded by frequent diet recall did not differ by study periods.

conclusionALLN-177 reduced 24-h UOx excretion, and was well tolerated. The results of this pilot study provided justification for further investigation of ALLN-177 in patients with secondary hyperoxaluria.

trial registrationClinicaltrials.gov NCT02289755.

Indexed as

Administration, OralAdultAgedCarboxy-LyasesDietEnzyme TherapyFemaleHumansHyperoxaluriaKidney CalculiMaleMiddle AgedOxalatesCarboxy-Lyasesoxalate decarboxylaseOxalatesreloxaliaseBariatric surgeryEnteric hyperoxaluriaNephrolithiasisOxalate

Identifiers

PMID30783888
PMCPMC6459785
OpenAlexW2915121090

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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 OpenQuestion graph.