Evidence map›Paper›PMID 40354041›Full record

ArticleJAMA pediatrics2025

Tacrolimus or Mycophenolate Mofetil for Frequently Relapsing or Steroid-Dependent Nephrotic Syndrome: A Randomized Clinical Trial.

Jingjing Wang, Fei Liu, Weili Yan, Jianhua Zhou, Yu Zhang, Liping Rong, Xiaoyun Jiang, Fei Zhao, Chunhua Zhu, Xiaochuan Wu and 20 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JAMA pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04048161 (Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04048161 phase4completednot on this map

Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome: a Randomized, Multicenter, Open-label, Parallel-arm Study

TypeinterventionalSponsorThe Children's Hospital of Zhejiang University School of MedicineRan2019 to 2023Enrolled270ConditionsNephrotic Syndrome in ChildrenArmsTacrolimus, Mycophenolate Mofetil
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

30 authors.

Jingjing WangDepartment of Nephrology, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Fei LiuDepartment of Nephrology, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Weili YanDepartment of Clinical Epidemiology and Clinical Trial Unit, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.
Jianhua ZhouDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yu ZhangDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Liping RongDepartment of Pediatric Nephrology and Rheumatology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Xiaoyun JiangDepartment of Pediatric Nephrology and Rheumatology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Fei ZhaoDepartment of Pediatric Nephrology, Children's Hospital of Nanjing Medical University, Nanjing, China.
Chunhua ZhuDepartment of Pediatric Nephrology, Children's Hospital of Nanjing Medical University, Nanjing, China.
Xiaochuan WuDepartment of Pediatrics, The Second Xiangya Hospital of Central South University, Changsha, China.
Xiaoyan LiDepartment of Pediatrics, The Second Xiangya Hospital of Central South University, Changsha, China.
Shuzhen SunDepartment of Pediatric Nephrology and Rheumatism and Immunology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
Jing WangDepartment of Pediatric Nephrology and Rheumatism and Immunology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
Mo WangDepartment of Nephrology, Children Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory, Chongqing, China.
Qin YangDepartment of Nephrology, Children Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory, Chongqing, China.
Hong XuDepartment of Nephrology, Children's Hospital of Fudan University, Shanghai, China.
Jing ChenDepartment of Nephrology, Children's Hospital of Fudan University, Shanghai, China.
Cuihua LiuDepartment of Pediatric Nephrology and Rheumatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.
Ming TianDepartment of Pediatric Nephrology and Rheumatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.
Shipin FengThe Affiliated Women's and Children's Hospital, School of Medicine, University of Electronic Science and Technology of China (UESTC), Chengdu, China.
Qinwei DuanThe Affiliated Women's and Children's Hospital, School of Medicine, University of Electronic Science and Technology of China (UESTC), Chengdu, China.
Xuhui ZhongDepartment of Pediatric Nephrology, Peking University First Hospital, Beijing, China.
Yun ZhuNephrology and Immunology Department of Children Hospital Affiliated to Soochow University, Suzhou, China.
Xiaozhong LiNephrology and Immunology Department of Children Hospital Affiliated to Soochow University, Suzhou, China.
Haidong FuDepartment of Nephrology, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Lingfei HuangDepartment of Pharmacy, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Daqing MaPerioperative and Systems Medicine Laboratory, Department of Anesthesiology, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Jie DingDepartment of Pediatric Nephrology, Peking University First Hospital, Beijing, China.
Qing YeDepartment of Laboratory Medicine, Children Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Jianhua MaoDepartment of Nephrology, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Both tacrolimus (TAC) and mycophenolate mofetil (MMF) are recommended for children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS). However, their comparative effectiveness and safety have not been evaluated through randomized clinical trials. Objective: To compare the effectiveness and safety of TAC and MMF in children with FRNS or SDNS. Design, Setting, and Participants: In this multicenter, open-label randomized clinical trial conducted at 12 pediatric nephrology centers across China, 270 children aged 2 to 18 years with FRNS or SDNS were allocated at a 1:1 ratio to treatment with either TAC or MMF. The study was conducted from November 2019 to July 2023, and data analysis was completed from July 2023 to March 2024. Intervention: Patients received either TAC (0.025-0.050 mg/kg, orally twice daily) or MMF (10-15 mg/kg, orally twice daily) for 1 year, along with a tapering regimen of steroids. Main Outcomes and Measures: The primary end point was 1-year relapse-free survival. Relapse frequency, cumulative steroid dosage, and safety profiles were also evaluated. Results: A total of 292 patients from 12 care centers were assessed for eligibility, and 270 patients were randomized to receive either TAC (n = 135) or MMF (n = 135). Among 270 patients, median (IQR) age was 6.91 (4.25-9.96) years, and 70 patients (25.9%) were female. Compared with MMF, the 1-year relapse-free survival rate in the TAC group was 1.86-fold higher (hazard ratio [HR], 2.86; 95% CI, 1.79-4.76; P < .001) in the intention-to-treat analysis. This difference was also significant after adjusting for the per-protocol analysis (HR, 2.78; 95% CI, 1.72-4.55; P < .001). The mean (SD) time to first relapse was significantly longer in the TAC group (323.99 [98.33] days) compared to the MMF group (263.21 [132.84] days). Furthermore, the TAC group showed a lower annual relapse rate than the MMF group (17.78% vs 41.48%) and required a significantly lower mean (SD) cumulative steroid dose (0.22 [0.10] mg/kg/day vs 0.34 [0.22] mg/kg/day). The safety profile was similar in both groups. Conclusions and Relevance: In this randomized clinical trial, compared with MMF, a 1-year course of TAC therapy significantly extended the period of relapse-free survival in children with FRNS or SDNS. Trial Registration: ClinicalTrials.gov Identifier: NCT04048161.

Identifiers

PMID40354041
PMCPMC12070277

What Socratic holds

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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 Socratic graph.