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

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 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


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

Value
https://center6.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