Clinical Trial: A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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 Cortic
Brief 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.
Detailed Summary:
Sponsor: Astellas Pharma Korea, Inc.
Current Primary Outcome: The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2 [ Time Frame: up to 8 weeks after treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The period until the UPCR is decreased below 0.2 [ Time Frame: up to 8 weeks after treatment ]
- The percentage of subjects who show relapse after the remission [ Time Frame: up to 24 weeks ]
- The period until the relapse happens from the complete remission [ Time Frame: up to 24 weeks ]
- Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays [ Time Frame: up to 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: December 6, 2012
Date Started: July 16, 2012
Date Completion: September 30, 2017
Last Updated: April 24, 2017
Last Verified: April 2017
