UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000384 |
|---|---|
| Receipt number | R000000477 |
| Scientific Title | The effects of tonsillectomy and steroid pulse therapy in patients with IgA nephropathy : multicenter,radomized trial |
| Date of disclosure of the study information | 2006/03/31 |
| Last modified on | 2016/03/31 12:09:45 |
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Basic information
Public title
The effects of tonsillectomy and steroid pulse therapy in patients with IgA nephropathy : multicenter,radomized trial
Acronym
tonsillectomy and steroid pulse therapy in IgA nephropathy
Scientific Title
The effects of tonsillectomy and steroid pulse therapy in patients with IgA nephropathy : multicenter,radomized trial
Scientific Title:Acronym
tonsillectomy and steroid pulse therapy in IgA nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology | Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify whether the combined therapy by tonsillectomy and steroid pulse therapy is more effective than steroid pulse therapy alone in terms of the induction of IgA nephropathy patients into clinical remission without proteinuria and hematuria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)change in 24-hour urinary protein excretion and the degree of microscopic hematuria from baseline, 2)percentage of patients with clinical remission, i.e., without proteinuria and hematuria
Key secondary outcomes
1)change in creatinine clearance from baseline, slope of 1/serum creatinine vs. time 2)incidence of events (doubling of serum creatinine or 50% decrease in creatinine clearance from baseline and dialysis) 3)percentage of adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
combined therapy by tonsillectomy and steroid pulse therapy
Interventions/Control_2
steroid pulse therapy 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
| 10 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with biopsy-prove IgA nephropathy
2)Relatively good prognosis group, relatively poor prognosis group and poor prognosis group
3)Urinary protein excretion is 1.0g/day or more and serum creatinine is less than 1.5mg/dl
4)Patients having chronic tonsillitis or recurrent tonsillitis
5)Systolic blood pressure is less than 140 mmHg and diastolic blood pressure is less than 90 mmHg with or without antihypertensive drugs
Key exclusion criteria
1)Patients with nephrotic syndorome
2)Patients whose serum creatinine is 1.6mg/dl or more
3)Patients who have been treated with steroid
4)Pregnant women or women of child bearing potential and nursing women.
5)Patients who can not be given anesthetic because of cardiac failure, respiratory failure or uncontrollable severe hypertension
6)Patients in whom tonsillectomy should not be done by the decision of otorhinolaryngologists because of the difficulty of tonsillectomy or no indication
7)Patients with hypersensitivity to the drugs used in the study
8)Patients who are judged to be inappropriate for the study by the investigator or subinvestigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Testuya Kawamura |
Organization
The Jikei University School of Medicine
Division name
Division of Kidney and Hypertension
Zip code
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL
03-3433-1111
kawatetu@coral.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Utsunomiya |
Organization
The Jikei University School of Medicine
Division name
Division of Kidney and Hypertension
Zip code
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL
03-3433-1111
Homepage URL
igahenteki@jikei.ac.jp
Sponsor or person
Institute
Research Group for Tonsillectomy and Steroid Pulse therapy in IgA naphropathy
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2005 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000477
