Pharmacokinetics of Tacrolimus in Children

Shandong University

Status and phase: Completed; Phase 4

Conditions: Nephrotic Syndrome

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT03347357

2017TAC002

Details and patient eligibility

About

the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.

Enrollment: 28 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients have been diagnosed with nephrotic syndrome;
• age range: 1 month to 18 years old
• tacrolimus used as part of regular treatment

Exclusion criteria

• expected survival time less than the treatment cycle;
• patients with other factors that researcher considers unsuitable for inclusion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

tacrolimus

Experimental group

Treatment:

Drug: Tacrolimus