Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03222687
• Date of registration: 07/07/2017
• Prospective Registration: No
• Primary sponsor: Shandong University
• Public title: Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis
• Scientific title: Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety
• Date of first enrolment: September 1, 2015
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03222687
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Contacts

• Name: Wei Zhao
• Affiliation: Shandong University

Key inclusion & exclusion criteria

Inclusion Criteria:

HSPN children Aged less than 18 years; receiving tacrolimus as initial immunosuppressive
therapy -

Exclusion Criteria:

Children received other immunosuppressive drug before the trial or other systemic trial
drug therapy; Children had a concomitant medical condition, whose participation, in the
opinion of the Investigator and/or medical advisor, may create an unacceptable additional
risk.



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Henoch-Schönlein Purpura Nephritis

Intervention(s)

Drug: prednisone

Drug: tacrolimus

Primary Outcome(s)

Complete remission [Time Frame: within 6 months]

Partial remission [Time Frame: within 6 months]

nonresponsive [Time Frame: within 6 months]

Secondary ID(s)

2017TAC001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors