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Recruitment status Main results already published
Unique ID issued by UMIN C000000384
Receipt No. 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

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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
Email 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
Email igahenteki@jikei.ac.jp

Sponsor
Institute Research Group for Tonsillectomy and Steroid Pulse therapy in IgA naphropathy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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