The Clinical Trial of ADR-001 for IgA Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and the tolerability of ADR-001 in Immunoglobulin A (IgA) Nephropathy patients. In addition, the investigators will evaluate the efficacy of ADR-001 for IgA Nephropathy patients.

Official 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

Conditions
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Glomerulonephritis , IGA

Intervention / Treatment
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* Biological: infusion of ADR-001 (Mesenchymal stem cell)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IgA nephropathy diagnosed by renal biopsy. 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. Over 20 years old. 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: Nephropathy other than IgA nephropathy, and primary and secondary nephrotic syndrome. 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. Treatment with other cells. Participated within 3 months or participating in other clinical trials . Penal transplantation within 3 years or scheduled. Diabetics not well controlled. Malignant neoplasm or history of malignant neoplasm within 5 years, or judged possibility of malignant tumor. Suspected of active infection. Positive for hepatitis B (HB), hepatitis C virus (HCV),human Immunodeficiency virus (HIV), human T-cell leukemia virus 1 (HTLV-1) or syphilis. History of severe hypersensitivity or anaphylactic reaction. Allergic to penicillin antibiotics, aminoglycoside antibiotics or dimethyl sulfoxide (DMSO). Serious complications not related to IgA nephropathy. 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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 3 + 3 dose escalation study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADR-001<br>Intravenous infusion of ADR-001 (Mesenchymal stem cell) | Biological: infusion of ADR-001 (Mesenchymal stem cell)<br>* Once or twice with two week interval at a dose of 100 x 10 ^ 6 cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Any adverse events are summarized. | until 6 weeks after first administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission (proteinuria, hematuria) | Ratio and time frame to achieve remission are summarized. | at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration | 
| Proteinuria | Change from baseline value and ratio to achieve threshold are summarized. | at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration | 
| Hematuria | Change from baseline value and ratio to achieve threshold are summarized. | at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration | 
| Estimated glomerular filtration rate (eGFR) | Change from baseline value are summarized. | at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration |