NCT01763580

A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 16 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.

Conditions

• MCNS
• Minimal Change Nephrotic Syndrome (MCNS)

Interventions

Type	Name	Description
DRUG	Tacrolimus	Oral
DRUG	Prednisolone	Oral

Timeline

• Start date: 2012-07-16
• Primary completion: 2017-05-02
• Completion: 2017-08-21
• First posted: 2013-01-09
• Last updated: 2024-10-31

Locations

1 site across 1 country: South Korea