Phase 4
N=77
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Nephrotic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01162005 ↗Enrolled (actual)
77
Serious AEs
5.2%
Results posted
Feb 2019
Primary outcome: Primary: Remission Rate — 34; 13 Participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tacrolimus (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission Rate |
34; 13 | 0.001 sig |
| SECONDARY Duration of Remission |
4.6; 4.0 | — |
Summary
To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents.
Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.
Eligibility Criteria
Inclusion Criteria
- Frequent relapse nephrotic syndrome
- steroid resistance nephrotic syndrome
Exclusion Criteria
- secondary nephrotic syndrome
- estimated glomerular filtration rate < 60 mL/min/1.73m2
- with active hepatitis
Data sourced from ClinicalTrials.gov (NCT01162005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.