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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 May 2023 |
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Main ID: |
NCT04342325 |
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Date of registration:
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08/04/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Clinical Trial of ADR-001 for IgA Nephropathy
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Scientific title:
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Open-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) Nephropathy |
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Date of first enrolment:
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June 15, 2020 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04342325 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shoichi Maruyama, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nagoya University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. IgA nephropathy diagnosed by renal biopsy.
2. Meet any of the following criteria.
i. Urinary protein at screening is 0.5 g / gCr or more and eGFR is 60 mL / min /
1.73m^2 or more even if corticosteroids are used for 6 months or more before
screening.
ii. Urine protein of 1.0 g / gCr or more and eGFR of 30 mL / min / 1.73 m^2 or more
and less than 60 mL / min / 1.73 m^2 at screening even if corticosteroids are used for
6 months or more before screening.
iii. Urine protein of 0.5 g / gCr or more and less than 1.0 g / gCr at screening and
eGFR of 20 mL / min / 1.73m^2 or more and 60 mL / min / 1.73m^2 or urine protein of
1.0 g / gCr or more at screening And eGFR is 20 mL / min / 1.73m^2 or more and less
than 30 mL / min / 1.73m^2.
3. Over 20 years old.
4. Able to provide informed consent.
However, in the first cohort, only 2) -i is applied in the selection criteria 2), and in
the second cohort, 2) -i, ii, and iii are applied.
Exclusion Criteria:
1. Nephropathy other than IgA nephropathy, and primary and secondary nephrotic syndrome.
2. Start or increase drug therapy for IgA nephropathy with corticosteroids,
immunosuppressants, renin angiotensin system (RAS ) inhibitors, antiplatelet drugs,
anticoagulants (warfarin), and n-3 fatty acids (fish oil) within 3 months . Palatal
tonsillectomy within 6 months.
3. Treatment with other cells.
4. Participated within 3 months or participating in other clinical trials .
5. Penal transplantation within 3 years or scheduled.
6. Diabetics not well controlled.
7. Malignant neoplasm or history of malignant neoplasm within 5 years, or judged
possibility of malignant tumor.
8. Suspected of active infection.
9. Positive for hepatitis B (HB), hepatitis C virus (HCV),human Immunodeficiency virus
(HIV), human T-cell leukemia virus 1 (HTLV-1) or syphilis.
10. History of severe hypersensitivity or anaphylactic reaction.
11. Allergic to penicillin antibiotics, aminoglycoside antibiotics or dimethyl sulfoxide
(DMSO).
12. Serious complications not related to IgA nephropathy.
13. Bleeding or may bleed, shallow days after surgery or trauma to the central nervous
system, history of hypersensitivity to components of heparin preparations, history of
heparin-induced thrombocytopenia Previous patient.
14. During pregnancy, lactation, may be pregnant or both men and women who do not agree to
give birth control under the guidance of the investigator or investigator during the
study period.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glomerulonephritis , IGA
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Intervention(s)
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Biological: infusion of ADR-001 (Mesenchymal stem cell)
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Primary Outcome(s)
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Incidence of adverse events
[Time Frame: until 6 weeks after first administration]
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Secondary Outcome(s)
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Hematuria
[Time Frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration]
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Clinical remission (proteinuria, hematuria)
[Time Frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration]
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Estimated glomerular filtration rate (eGFR)
[Time Frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration]
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Proteinuria
[Time Frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration]
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Secondary ID(s)
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jRCT2043200002
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CAMCR013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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