The Clinical Trial of ADR-001 for IgA Nephropathy

Open-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) Nephropathy

NCT04342325•Nagoya University

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (2)

Kasugai Municipal Hospital

Kasugai, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Key Dates

Start Date

June 15, 2020

Primary Completion Date

November 1, 2022

Completion Date

March 31, 2023

Last Updated

May 1, 2023

Enrollment

ACTUAL participants

Conditions

Glomerulonephritis , IGA

Interventions

infusion of ADR-001 (Mesenchymal stem cell)

BIOLOGICAL