Evidence map›Paper›PMID 29340321›Full record

ArticleKidney international reports2018

Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome.

Howard Trachtman, Debbie S Gipson, Michael Somers, Cathie Spino, Sharon Adler, Lawrence Holzman, Jeffrey B Kopp, John Sedor, Sandra Overfield, Ayanbola Elegbe and 2 more

Open access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
2.0field-weighted citation impact, top 13% 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

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Interventions for minimal change disease in adults with nephrotic syndrome.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
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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

12 authors at 9 institutions in 1 country.

Howard TrachtmanDivision of Nephrology, Department of Pediatrics, New York University Langone Medical Center, New York, New York, USA.
Debbie S GipsonDepartment of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.
Michael SomersDivision of Nephrology, Boston Children's Hospital, Boston, Massachusetts, USA.
Cathie SpinoDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.
Sharon AdlerDivision of Nephrology and Hypertension, Harbor-University of California Los Angeles Medical Center, Los Angeles, California, USA.
Lawrence HolzmanDepartment of Medicine, University of Pennsylvania Medical School, Philadelphia, Pennsylvania, USA.
Jeffrey B KoppKidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.
John SedorDepartment of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Sandra OverfieldBristol-Myers Squibb, Princeton, New Jersey, USA.
Ayanbola ElegbeBristol-Myers Squibb, Princeton, New Jersey, USA.
Michael MaldonadoBristol-Myers Squibb, Princeton, New Jersey, USA.
Anna GrekaDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, and Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge, Massachusetts, USA.
Bristol-Myers Squibb (United States) · USUniversity of Michigan–Ann Arbor · USBoston Children's Hospital · USBrigham and Women's Hospital · USLos Angeles Medical Center · USNational Institute of Diabetes and Digestive and Kidney Diseases · USNYU Langone Health · USUniversity of Pennsylvania · USUniversity School · US

Funding

Project-005UL1TR001445 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BREDELLA, MIRIAM ANTOINETTE, HOCHMAN, JUDITH S · 2015 to 2025
$103.5M
Molecular mechanisms of podocyte injury in FSGSR01DK095045 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Anna Greka, Juan Lorenzo Pablo · 2014 to 2026
$5.1M
Role of TRPC5 channel inhibition in the treatment of glomerular diseaseR01DK099465 · NIDDK · BROAD INSTITUTE, INC. · PI Anna Greka · 2014 to 2026
$5.1M
NCATS NIH HHS UL1 TR001445NIDDK NIH HHS R01 DK095045NIDDK NIH HHS R01 DK099465
6 · The paper itself

Abstract

introductionTreatment-resistant nephrotic syndrome is a rare form of glomerular disease that occurs in children and adults. No Food and Drug Administration-approved treatments consistently achieve remission of proteinuria and preservation of kidney function. CD80 (B7-1) can be expressed on injured podocytes, and administration of abatacept (modified CTLA4-Ig based on a natural ligand to CD80) has been associated with sustained normalization of urinary protein excretion and maintenance of glomerular filtration rate in experimental and clinical settings.

methodsIn this report, we describe the rationale for and design of a randomized, placebo-controlled, clinical trial of abatacept in patients with treatment-resistant nephrotic syndrome caused by focal segmental glomerulosclerosis or minimal change disease. The design is a hybrid of a parallel-group and crossover design (switchover) with the primary objectives assessed in the first period of the study and the secondary objectives assessed using data from both periods. All participants will receive the active agent in 1 of the periods. The duration of treatment will be 4 months per period.

resultsThe primary outcome will be improvement in nephrotic-range proteinuria to subnephrotic range, that is, reduction from baseline to 4 months in urine protein:creatinine ratio ≥ 50% and to a level < 3. The projected sample size is 90 patients, which has 80% power to detect a treatment difference of 28%.

conclusionThis study advances efforts to validate CD80 as a therapeutic target for treatment-resistant nephrotic syndrome, and implements a precision medicine-based approach to this serious kidney condition in which the selection of a therapeutic agent is guided by the underlying disease mechanism operating in individual patients.

Indexed as

albuminuriachronic kidney diseaseglomerular diseasepodocyteproteinuria

Identifiers

PMID29340321
PMCPMC5762951
OpenAlexW2751639818

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.