UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003245 |
|---|---|
| Receipt number | R000003731 |
| Scientific Title | A Comparative Study of Neoral in combination with Corticosteroid comparing to Corticosteroid alone in patients with Nephrotic syndrome |
| Date of disclosure of the study information | 2010/02/26 |
| Last modified on | 2010/02/23 18:32:22 |
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Basic information
Public title
A Comparative Study of Neoral in combination with Corticosteroid comparing to Corticosteroid alone in patients with Nephrotic syndrome
Acronym
A Comparative Study of Neoral in patients with Nephrotic syndrome.
Scientific Title
A Comparative Study of Neoral in combination with Corticosteroid comparing to Corticosteroid alone in patients with Nephrotic syndrome
Scientific Title:Acronym
A Comparative Study of Neoral in patients with Nephrotic syndrome.
Region
| Japan |
Condition
Condition
Nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A primary objectives is to assess long-term efficacy and safety of Neoral in combination with corticosteroid comparing to conventional therapy which is to use corticosteroid alone in patients with initial, frequent recurrent or steroid dependent Nephrotic Syndrome. And a co-primary objective is to evaluate optimal usage of Neoral in those patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Urine protein (mg/day)
Key secondary outcomes
Remission
Frequency of Recurrence
Duration of hospitalization
Cumulative dose of corticosteroid
Creatinine Clearance
Serum Creatinine
Serum albumin
Total protein (serum)
Total cholesterol (serum)
Edema
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with prednisolone and Neoral.
Interventions/Control_2
Treatment with prednisolone alone.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with initial, frequent recurrent or steroid dependent Nephrotic Syndrome who are full filled following criteria.
1. Patients who are diagnosed as nephritic syndrome defined by the diagnosis criteria of nephritic syndrome authorized by MHLW
2. Patients who are 18 to 75 years old in principle.
3. Patients who are either outpatients or hospitalization.
4. Patients who have not taken any cyclosporine products
5. Patients who have written consent to participate in this study.
Key exclusion criteria
Exclusion Criteria
Patients who meet following criteria will be excluded from this study.
1. Patients with renal impairment that is defined as that creatinin clearance is less than 50ml/min calculated from serum creatinin and from pooled urine creatinin.
2. Patients who are diagnosed as a steroid resistant nephrotic syndrome.
3. Patients who have to take any drugs, which have renal toxicity.
4. Patients with malignancy or history of malignancy.
5. Patients who have uncontrollable hypertension by any treatment.
6. Patients with malabsorption syndrome, cerebral circulatory disturbance or seizure
7. Patients with cardiac, liver or pancreatic severe disease
8. Patients who are pregnancy, lactation or suspicion of pregnancy.
9. Patients who are considered that immunosuppressive drugs should not be used due to infection.
10. Patients who have an episode of allergic reaction to any ingredients of Neoral.
11. Patients who are judged ineligible to enroll into this trial due to any reasons by the study physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Fukatsu |
Organization
Kyoto university hospital
Division name
Nephrology section
Zip code
Address
54 Kawahara-cho, syougoin, sakyou-ku, Kyoto
TEL
075-751-3641
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Iehara |
Organization
kyoto university hospital
Division name
Nephrology section
Zip code
Address
54 Kawahara-cho, syougoin, sakyou-ku, Kyoto
TEL
075-751-3641
Homepage URL
niehara@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto City Hospital
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 23 | Day |
Last modified on
| 2010 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003731
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| Registered date | File name |
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