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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000380 |
Receipt No. | R000000441 |
Scientific Title | The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial |
Date of disclosure of the study information | 2006/03/31 |
Last modified on | 2014/04/01 |
Basic information | ||
Public title | The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial | |
Acronym | ARB and IgA nephropathy | |
Scientific Title | The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial | |
Scientific Title:Acronym | ARB and IgA nephropathy | |
Region |
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Condition | ||
Condition | IgA nephropathy | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim is to compare a clinical difference of renoprotective effects and an influence on renin-angiotensin-aldosterone system with valsartan and enalapril in IgA nephropathy patients with hypertensin. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | 1)change in Ccr,2)inverse of inclination of serum Cr value, 3)change in urinary protein excretion, 4)inidence of events (doubling of serum creatinine concentration, 50% decrease in Ccr from the baseline value, dialysis) |
Key secondary outcomes | 1)change in PRA and PCA, 2)hyperkalemia, 3)tolerability (drug discontinuation rate) |
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 |
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Interventions/Control_1 | ARB valsartan
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Interventions/Control_2 | ACE-I enalapril | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)patients with IgA nephropathy proven by renal biopsy
2)patients aged over 16 years and 75 years or less 3)patients who have urinary protein of over 0.5g/day 4)Patients with a serum creatinine value of 3mg/dL or less. 5)IgA nephropathy patients with hypertension (over 140 mmHg in SBP and over 90 mmHg in DBP) treated with or without antihypertensive agents except ARBs and ACE-Is. |
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Key exclusion criteria | 1)patients with nephrotic syndorome.
2)patients who administered steroid or discontinuted within 6 months prior to enrolment in the study. 3)patients with serious liver dysfunction. 4)pregnant women or women of child bearing potential and nursing women. 5)patients with hypersensitivity to angiotensin II receptor blocker and angiotensin convertig enzyme inhibitor. 6)Other patients who are judged to be inappropriate for the study by the investigator or subinvestigator. |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The Jikei University School of Medicine | ||||||
Division name | Department of Internal Medicine | ||||||
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 |
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Organization | The Jikei University School of Medicine | ||||||
Division name | Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan | ||||||
TEL | 03-3433-1111 | ||||||
Homepage URL | |||||||
yoichimiyazaki@jikei.ac.jp |
Sponsor | |
Institute | ARB therapeutic society of IgA nephropathy |
Institute | |
Department |
Funding Source | |
Organization | The Kidney Foundation,Japan |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
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Results | |
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Results Delayed | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000441 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |