Evidence map›Paper›PMID 39706676›Full record

ArticleLupus science & medicine2024

Lupus nephritis randomised controlled trials: evidence gaps and under-represented groups.

Alberto Nordmann-Gomes, Gabriel Cojuc-Konigsberg, Adriana Hernández-Andrade, Valeria Navarro-Sánchez, Juan Carlos Ramírez-Sandoval, Brad Rovin, Juan M Mejia-Vilet

Abstract readScoping Review
In one paragraph

Article in Lupus science & medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–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.

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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Is It Time to Change Our Approach to Childhood Lupus Nephritis?Journal of the American Society of Nephrology : JASN · 2026
    Article
  4. 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

7 authors.

Alberto Nordmann-GomesSchool of Medicine, Universidad Panamericana, Mexico City, Mexico.ORCID 0009-0008-9763-8209
Gabriel Cojuc-KonigsbergDepartment of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Adriana Hernández-AndradeDepartment of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Valeria Navarro-SánchezDepartment of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Juan Carlos Ramírez-SandovalDepartment of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Brad RovinInternal Medicine/Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.ORCID 0000-0001-5639-0210
Juan M Mejia-ViletDepartment of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico jmmejia@hotmail.com.ORCID 0000-0003-4062-9412

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe performed a scoping review of randomised clinical trials (RCTs) assessing pharmacological therapies for the initial management of lupus nephritis (LN), focusing on study design, included populations and outcome definitions, to assess the generalisability of their results and identify gaps in the evidence.

methodsRCTs evaluating pharmacological interventions for the initial therapy of LN published between 2000 and 2024 were evaluated. Extracted variables included study design, selection criteria, outcome definitions, populations recruited and clinical characteristics of participants. Each study arm was included as intervention and segregated into guideline-recommended regimens (cyclophosphamide (CYC), mycophenolic acid analogues (MPAAs), calcineurin inhibitors and belimumab) or other regimens. Data were analysed by descriptive statistics, and Fragility Index (FI) was estimated to assess robustness of studies.

resultsWe included 124 intervention arms within 61 RCT, involving 7058 participants. Seventy-nine arms (63.7%) corresponded to guideline-recommended therapies: 33 (26.6%) MPAA, 28 (22.6%) NIH-CYC and 7 (5.6%) triple-drug therapies. While 100% of triple-drug therapies RCT were multinational, only 7.1% of NIH-CYC and 0% of tacrolimus RCTs were conducted in more than one country. Only 9 (14.8%) had follow-up ≥24 months. Ten (16.4%) RCTs exclusively included participants with severe or refractory LN. Only 29 (47.5%) reported serious adverse events, and few described patient-reported outcomes. Black and other race participants were under-represented, as well as participants from Middle East, North Africa, and the sub-Saharan African region. Response was variably defined and assessed at different intervals. Robustness of RCTs evaluating double-drug guideline-recommended therapies were mostly low, with FI ranging from 1 to 3.

conclusionsConsidering new recommendations for the management of LN, we call for broader inclusion of under-represented populations and homogenisation of study design. This study provides the rationale for evaluating unexplored treatment comparisons and conducting research on newer interventions in clinical settings where evidence is currently lacking.

Indexed as

CyclophosphamideImmunosuppressive AgentsLupus NephritisRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedCalcineurin InhibitorsDrug Therapy, CombinationEvidence GapsHumansMycophenolic AcidAntibodies, Monoclonal, HumanizedbelimumabCalcineurin InhibitorsCyclophosphamideImmunosuppressive AgentsMycophenolic AcidClinical TrialLupus NephritisOutcome Assessment, Health CarePatient Reported Outcome MeasuresSystemic Lupus Erythematosus

Identifiers

PMID39706676
PMCPMC11664369

What OpenQuestion holds

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Registered trials

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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.