Evidence map›Paper›PMID 39810771›Full record

ArticleKidney international reports2025

Study Design and Baseline Characteristics of ALIGN, a Randomized Controlled Study of Atrasentan in Patients With IgA Nephropathy.

Hiddo J L Heerspink, Meg Jardine, Donald E Kohan, Richard A Lafayette, Adeera Levin, Adrian Liew, Hong Zhang, Irene Noronha, Hernan Trimarchi, Fan Fan Hou and 4 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Kidney international reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04573478 (A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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.

NCT04573478 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

TypeinterventionalSponsorNovartis PharmaceuticalsRan2020 to 2028Enrolled404ConditionsIgA Nephropathy, Immunoglobulin A NephropathyArmsAtrasentan, Placebo, Zigakibart
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Meg JardineThe George Institute for Global Health, Syndey, Australia.
Donald E KohanDivision of Nephrology, University of Utah Health, Salt Lake City, Utah, USA.
Richard A LafayetteDivision of Nephrology, Stanford University, Stanford, California, USA.
Adeera LevinDivision of Nephrology, The University of British Columbia, Vancouver, British Columbia, Canada.
Adrian LiewThe Kidney and Transplant Practice, Mount Elizabeth Novena Hospital, Singapore, Singapore.
Hong ZhangRenal Division, Peking University First Hospital, Beijing, Beijing, China.
Irene NoronhaRenal Division, Hospital Beneficência Portuguesa de São Paulo, São Paulo, Brazil.
Hernan TrimarchiDivision of Nephrology and Renal Transplantation, Hospital Británico de Buenos Aires, Buenos Aires, Argentina.
Fan Fan HouDivision of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China.
Ronny RenfurmNovartis Pharmaceuticals AG, Basel, Switzerland.
Todd GrayChinook Therapeutics, A Novartis Company, Seattle, Washington, USA.
Marianne CamargoChinook Therapeutics, A Novartis Company, Seattle, Washington, USA.
Jonathan BarrattDepartment of Cardiovascular Sciences, University of Leicester, Leicester, Leicestershire, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Endothelin A (ETA) receptor activation is a driver of proteinuria, kidney inflammation, and fibrosis in IgA nephropathy (IgAN). Atrasentan, a selective ETA receptor antagonist, has potential to reduce proteinuria and preserve kidney function in IgAN. ALIGN (NCT04573478) is a phase 3, randomized, double-blind, placebo-controlled clinical trial of atrasentan in patients with IgAN at high risk of kidney function loss. Methods: Eligibility criteria for the ALIGN main stratum included patients with biopsy-proven IgAN, total protein excretion ≥ 1 g/d, estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m Results: Enrolment occurred across 20 countries; 404 patients were randomized: 340 in the main stratum and 64 in the SGLT2i stratum. At baseline in the main stratum, mean age was 44.7 years, 42.4% were female, mean eGFR and median UPCR were 58.9 ml/min per 1.73 m Conclusion: The ongoing ALIGN trial evaluates the efficacy and safety of atrasentan in a representative global IgAN population at risk for disease progression despite optimized RAS inhibitor therapy and includes an exploratory stratum evaluating atrasentan use in combination with an SGLT2i.

Indexed as

atrasentanendothelin receptor antagonistIgA nephropathy

Identifiers

PMID39810771
PMCPMC11725817

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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.