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The Clinical Trial of ADR-001 for IgA Nephropathy

Primary Purpose

Glomerulonephritis , IGA

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

infusion of ADR-001 (Mesenchymal stem cell)

About this trial

This is an interventional treatment trial for Glomerulonephritis , IGA

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kasugai Municipal Hospital
Nagoya University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADR-001

Arm Description

Intravenous infusion of ADR-001 (Mesenchymal stem cell)

Outcomes

Primary Outcome Measures

Incidence of adverse events

Any adverse events are summarized.

Secondary Outcome Measures

Clinical remission (proteinuria, hematuria)

Ratio and time frame to achieve remission are summarized.

Proteinuria

Change from baseline value and ratio to achieve threshold are summarized.

Hematuria

Change from baseline value and ratio to achieve threshold are summarized.

Estimated glomerular filtration rate (eGFR)

Change from baseline value are summarized.

Full Information

NCT ID

NCT04342325

First Posted

April 8, 2020

Last Updated

April 27, 2023

Sponsor

Nagoya University

Collaborators

Rohto Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04342325

Brief Title

The Clinical Trial of ADR-001 for IgA Nephropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 15, 2020 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nagoya University

Collaborators

Rohto Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glomerulonephritis , IGA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

3 + 3 dose escalation study design

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADR-001

Arm Type

Experimental

Arm Description

Intravenous infusion of ADR-001 (Mesenchymal stem cell)

Intervention Type

Biological

Intervention Name(s)

infusion of ADR-001 (Mesenchymal stem cell)

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events

Description

Any adverse events are summarized.

Time Frame

until 6 weeks after first administration

Secondary Outcome Measure Information:

Title

Clinical remission (proteinuria, hematuria)

Description

Ratio and time frame to achieve remission are summarized.

Time Frame

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

Title

Proteinuria

Description

Change from baseline value and ratio to achieve threshold are summarized.

Time Frame

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

Title

Hematuria

Description

Change from baseline value and ratio to achieve threshold are summarized.

Time Frame

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

Title

Estimated glomerular filtration rate (eGFR)

Description

Change from baseline value are summarized.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shoichi Maruyama, MD, PhD

Organizational Affiliation

Nagoya University

Official's Role

Study Chair

Facility Information:

Facility Name

Kasugai Municipal Hospital

City

Kasugai

State/Province

Aichi

ZIP/Postal Code

486-8510

Country

Japan

Facility Name

Nagoya University Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

566-8560

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35692547

Citation

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.

Results Reference

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The Clinical Trial of ADR-001 for IgA Nephropathy

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