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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04342325
Other study ID # CAMCR013
Secondary ID jRCT2043200002
Status Completed
Phase Phase 1
First received
Last updated
Start date June 15, 2020
Est. completion date March 31, 2023

Study information

Verified date April 2023
Source Nagoya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date March 31, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Intervention

Biological:
infusion of ADR-001 (Mesenchymal stem cell)
Once or twice with two week interval at a dose of 100 x 10 ^ 6 cells.

Locations

Country Name City State
Japan Kasugai Municipal Hospital Kasugai Aichi
Japan Nagoya University Hospital Nagoya Aichi

Sponsors (2)

Lead Sponsor Collaborator
Nagoya University Rohto Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Any adverse events are summarized. until 6 weeks after first administration
Secondary 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
Secondary 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
Secondary 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
Secondary Estimated glomerular filtration rate (eGFR) Change from baseline value are summarized. at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration