Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2043200002 | Other Identifier | Japan Registry of Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rohto Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADR-001 | Experimental | Intravenous infusion of ADR-001 (Mesenchymal stem cell) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infusion of ADR-001 (Mesenchymal stem cell) | Biological | Once or twice with two week interval at a dose of 100 x 10 ^ 6 cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Any adverse events are summarized. | until 6 weeks after first administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proteinuria | Change from baseline value and ratio to achieve threshold are summarized. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shoichi Maruyama, MD, PhD | Nagoya University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasugai Municipal Hospital | Kasugai | Aichi-ken | 486-8510 | Japan | ||
| Nagoya University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39186380 | Derived | 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. | |
| 35692547 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
3 + 3 dose escalation study design
Not provided
Not provided
Not provided
Not provided
| at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration |
| 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 |
| Estimated glomerular filtration rate (eGFR) | Change from baseline value are summarized. | at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration |
| Nagoya |
| Aichi-ken |
| 566-8560 |
| Japan |
| 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |