|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 August 2022 |
|
Main ID: |
NCT01763580 |
|
Date of registration:
|
06/12/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
T-OPTIMUM |
|
Scientific 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 Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) |
|
Date of first enrolment:
|
July 16, 2012 |
|
Target sample size:
|
144 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01763580 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Medical Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Astellas Pharma Inc |
| | |
|
Key inclusion & exclusion criteria
|
|
Health Condition(s) or Problem(s) studied
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|