The Clinical Trial of ADR-001 for IgA Nephropathy

JRCT ID: jRCT2043200002

Registered date:14/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Glomerulonephritis, IGA
• Date of first enrollment: 01/10/2020
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Administered ADR-001 intravenously once or twice with two week interval at a dose of 100 x 10 ^ 6 cells.

Outcome(s)

• Primary Outcome: Incidence of adverse events up to 6 weeks after the first dose

Secondary Outcome

1) Clinical remission (proteinuria, hematuria) and time to remission
2) Proteinuria
3) Hematuria
4) eGFR

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Maruyama Shoichi
• Source(s) of Monetary Support: ROHTO Pharmaceutical Co.,Ltd.
• Secondary ID(s): NCT04342325