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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000373 |
Receipt No. | R000000467 |
Scientific Title | Lisinopril for IgA nephropathy with focal mesangial proliferation in children |
Date of disclosure of the study information | 2006/04/01 |
Last modified on | 2014/03/14 |
Basic information | ||
Public title | Lisinopril for IgA nephropathy with focal mesangial proliferation in children | |
Acronym | Lisinopril for IgA nephropathy with focal mesangial proliferation in children | |
Scientific Title | Lisinopril for IgA nephropathy with focal mesangial proliferation in children | |
Scientific Title:Acronym | Lisinopril for IgA nephropathy with focal mesangial proliferation in children | |
Region |
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Condition | |||
Condition | IgA nephropathy in children | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We investigate efficacy and safety of lisinopril for IgA nephropathy with focal mesangial proliferation in children. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Disappearance rate of proteinuria |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Lisinopril for 2 years | |
Interventions/Control_2 | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Biopsy diagnoses of IgA nephropathy with focal mesangial proliferation.
2.Proteinuria with a urinary protein-creatinine ratio >0.2. 4.Aged 2 to 18 years. 5.Written informed consent from the patients' parents or legal guardians. |
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Key exclusion criteria | 1.Other renal or systemic forms defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus).
2.Medical history of allergy or hypersensitivity reactions to lisinopuril. 3.Chronic renal dysfunction. 4.Active infectious disease. 5.Severe liver disfunction. 6.History of steroid, immunosupression, ACEI, ARB, Saireito and dipilidamol administration. 7.Pregnancy. 8.Judged inappropriate for this study by the physicians. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Wakayama Medical University | ||||||
Division name | Department of Pediatrics | ||||||
Zip code | |||||||
Address | 811-1 Kimiidera Wakayama City Wakayama | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | The Japanese Pediatric IgA Nephropathy of Treatment Study Group | ||||||
Division name | Department of Pediatrics, Wakayama Medical University | ||||||
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Sponsor | |
Institute | The Japanese Pediatric IgA Nephropathy of Treatment Study Group |
Institute | |
Department |
Funding Source | |
Organization | The Kidney Foundation, Japan |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 | 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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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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=R000000467 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |