CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 270 enrolled
Drug / intervention
Tacrolimus +1 moredrug
Likely dose
Tacrolimus 0.10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04048161
NCT04048161Phase 4Completed
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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

The Children's Hospital of Zhejiang University School of Medicine·interventional·Posted Aug 7, 2019·Updated Oct 17, 2023

In Brief

A Phase 4 clinical trial evaluating Tacrolimus and Mycophenolate Mofetil for Nephrotic Syndrome in Children. Completed, enrolled 270 participants across 12 sites.

Detailed Summary

Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is uesful for primary nephrotic syndrome, proning to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment, and the usage of immunosuppressive agents has become a new choice for the treatment of such patients. This study is a prospective, randomized, multicenter, open, parallel controlled trial, evaluating the efficacy and safety of steroid combined with the immunosuppressive agents which are tacrolimus and mycophenolate mofetil to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNephrotic Syndrome in Children
CountriesChina
CollaboratorsChildren's Hospital of Fudan University, Peking University First Hospital, First Affiliated Hospital of Zhongshan Medical University, Nanjing Children's Hospital, Chengdu Women and Children's Center Hospital, Tongji Hospital, Second Xiangya Hospital of Central South University, Children's Hospital of Chongqing Medical University, Children's Hospital of Soochow University, Henan Provincial People's Hospital, Shandong Provincial Hospital

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedAug 7, 2019
Enrollment StartNov 12, 2019
Primary CompletionMay 31, 2023
Study CompletionJul 12, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.9 years ago

Interventions

Tacrolimusdrug

The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml，then reduce the dosage of drugs to maintian the concentration for tacrolimus is \< 5ng/ml. Total duration : 1 year. Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.

Mycophenolate Mofetildrug

The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20\~30mg/kg/day，BID. The concentration for MPA-AUC is 30\~50 μg.h/ml，then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year. Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.