Unique ID issued by UMIN | UMIN000027185 |
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Receipt number | R000031098 |
Scientific Title | The efficacy and safety of preprandial Neoral once-daily administration for adult patients with Minimal Change Nephrotic Syndrome |
Date of disclosure of the study information | 2017/04/28 |
Last modified on | 2017/04/28 18:16:12 |
The efficacy and safety of preprandial Neoral once-daily administration for adult patients with Minimal Change Nephrotic Syndrome
The efficacy of preprandial Neoral once-daily administration for MCNS
The efficacy and safety of preprandial Neoral once-daily administration for adult patients with Minimal Change Nephrotic Syndrome
The efficacy of preprandial Neoral once-daily administration for MCNS
Japan |
Minimal change nephrotic syndrome
Nephrology |
Others
NO
On this trial we evaluate the efficacy and safety of preprandial Neoral once-daily administration for suppressing relapse of adult new-onset MCNS patients using C2 monitoring.
Safety,Efficacy
The primary efficacy endpoints were the duration of remission and the relapse rate.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
The initial dosage of steroid was 0.8 mg perkg per day. If the proteinuria decreased to 1 g per day, the initial dosage was maintained for 2 weeks, and then the dosage was reduced to 0.6 mg per kg per day. The dosage was then decreased by 0.1 mg per kg per day every 2 weeks, and the steroid was discontinued after a target of 4 months. If the proteinuria decreased to 1 g/day on the steroid treatment, Neoral was added in combination, at an initial dosage of 2 mg per kg per day, once daily before breakfast.
The initial dosage of steroid was 0.8 mg per
kg per day (maximum dosage: 60 mg). If the proteinuria decreased to 1g per day, the initial dosage was maintained for 2 weeks, and the dosage was then reduced to 0.6 mg per kg per day. After that, the dosage was decreased by 0.1 mg/kg/day every 4 weeks. Four weeks after the dosage reached 15 mg per day, it was changed to 20 mg per alternate days, and this dose was maintained for approximately half a year. Thereafter, the dosage was reduced every 8 weeks by 5 mg per alternate days, and the steroid was discontinued after a target of half a year.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
They had been admitted to St. Marianna University School of Medicine Hospital from 2007 to 2010 and were subsequently diagnosed with new-onset MCNS by renal biopsy.
Patients with systemic disease, malignant tumors, diabetes, liver disease, or chronic kidney disease (CKD) were excluded from this study.
22
1st name | |
Middle name | |
Last name | Sayuri Shirai |
St. Marianna University School of Medicine
nephrology and hypertension
Sugao 2-16-1 Miyamae-ku Kawasakishi
044-977-8111
sirababu@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Sayuri Shirai |
St. Marianna University School of Medicine
nephrology and hypertension
Sugao 2-16-1 Miyamae-ku Kawasakishi
044-977-8111
sirababu@marianna-u.ac.jp
St. Marianna University School of Medicine
St. Marianna University School of Medicine
Self funding
NO
2017 | Year | 04 | Month | 28 | Day |
Partially published
Completed
2006 | Year | 09 | Month | 27 | Day |
2006 | Year | 10 | Month | 01 | Day |
2017 | Year | 04 | Month | 28 | Day |
2017 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031098
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