The Clinical Trial of ADR-001 for IgA Nephropathy

NCT04342325 | Completed Phase 1 DMC

• 2 other identifiers: CAMCR013jRCT2043200002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glomerulonephritis , IGA

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Any adverse events are summarized.

  until 6 weeks after first administration

Secondary Outcomes (4)

• Clinical remission (proteinuria, hematuria)

  at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration

• Proteinuria

  at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration

• Hematuria

  at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration

• Estimated glomerular filtration rate (eGFR)

  at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration

Study Arms (1)

ADR-001

EXPERIMENTAL

Intravenous infusion of ADR-001 (Mesenchymal stem cell)

Biological: infusion of ADR-001 (Mesenchymal stem cell)

Interventions

infusion of ADR-001 (Mesenchymal stem cell) BIOLOGICAL

Once or twice with two week interval at a dose of 100 x 10 \^ 6 cells.

ADR-001

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nagoya University: lead
• Rohto Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Kasugai Municipal Hospital

Kasugai, Aichi-ken, 486-8510, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 566-8560, Japan

Location

Related Publications (2)

• Tanaka A, Furuhashi K, Fujieda K, Horinouchi A, Maeda K, Saito S, Mimura T, Saka Y, Naruse T, Ishimoto T, Kato N, Kosugi T, Kinoshita F, Kuwatsuka Y, Nakai Y, Maruyama S. Safety and Tolerability of Adipose-Derived Mesenchymal Stem Cell (ADR-001) Therapy for IgA Nephropathy. Kidney360. 2024 Nov 1;5(11):1692-1705. doi: 10.34067/KID.0000000000000563. Epub 2024 Aug 26.

  PMID: 39186380 DERIVED

• Tanaka A, Furuhashi K, Fujieda K, Maeda K, Saito S, Mimura T, Saka Y, Naruse T, Ishimoto T, Kosugi T, Kinoshita F, Kuwatsuka Y, Shimizu S, Nakai Y, Maruyama S. Protocol for a Phase 1, Open-Label, Multiple-Center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 in the Treatment of Immunoglobulin A Nephropathy. Front Med (Lausanne). 2022 May 27;9:883168. doi: 10.3389/fmed.2022.883168. eCollection 2022.

  PMID: 35692547 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shoichi Maruyama, MD, PhD

  Nagoya University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Department of Nephrogy, Graduate school of Medicine

Model Details: 3 + 3 dose escalation study design

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: June 15, 2020
• Primary Completion: November 1, 2022
• Study Completion: March 31, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)