Glomerulonephritis , IGAPhase 1NCT04342325
The Clinical Trial of ADR-001 for IgA Nephropathy
A Phase 1 study testing infusion of ADR-001 (Mesenchymal stem cell) in people with Glomerulonephritis , IGA, run by Nagoya University at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glomerulonephritis , IGA
- What is being tested?
- infusion of ADR-001 (Mesenchymal stem cell)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesJapan
- Study dates
- 15 Jun 2020to 31 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IgA nephropathy diagnosed by renal biopsy.
- Meet any of the following criteria.
- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510
Nagoya University Hospital
Nagoya, Aichi-ken, 566-8560
About this study
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
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
- Being tested
- infusion of ADR-001 (Mesenchymal stem cell)
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion of ADR-001 (Mesenchymal stem cell)Biological
Once or twice with two week interval at a dose of 100 x 10 ^ 6 cells.
| Study group | Role | What they receive |
|---|---|---|
| ADR-001 | Experimental | Intravenous infusion of ADR-001 (Mesenchymal stem cell) Receives: Biological: infusion of ADR-001 (Mesenchymal stem cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Any adverse events are summarized.
Measured: until 6 weeks after first administration
Secondary outcomes (4)
Clinical remission (proteinuria, hematuria)
Ratio and time frame to achieve remission are summarized.
Measured: 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.
Measured: 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.
Measured: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Estimated glomerular filtration rate (eGFR)
Change from baseline value are summarized.
Measured: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start15 Jun 2020
- Primary completion1 Nov 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis , IGAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 + 3 dose escalation study design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Collaborators
- Rohto Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Shoichi Maruyama MD PhD, Nagoya University
- Investigators
- Shoichi Maruyama, MD, PhD, Study chair, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342325
- Sponsor's protocol ID
- CAMCR013
- Other IDs
- jRCT2043200002
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2020
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39186380Tanaka 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.
PubMed 35692547
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04342325
- Acronym / sponsor ID
- CAMCR013
- Conditions
- Glomerulonephritis , IGA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Collaborators
- Rohto Pharmaceutical Co., Ltd.
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 + 3 dose escalation study design
| Arm | Type | Receives |
|---|---|---|
| ADR-001 | Experimental | Biological: infusion of ADR-001 (Mesenchymal stem cell)Intravenous infusion of ADR-001 (Mesenchymal stem cell) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- IgA nephropathy diagnosed by renal biopsy.
- Meet any of the following criteria.
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infusion of ADR-001 (Mesenchymal stem cell)Once or twice with two week interval at a dose of 100 x 10 ^ 6 cells. | Biological | ADR-001 |
Primary outcome
Incidence of adverse events
Time frame: until 6 weeks after first administration
Any adverse events are summarized.
4 secondary outcomes
Clinical remission (proteinuria, hematuria)
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Proteinuria
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Hematuria
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Estimated glomerular filtration rate (eGFR)
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 39186380Tanaka 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.
- Derived from this study: PubMed 35692547Tanaka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoichi Maruyama, MD, PhD study chair
Nagoya University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing infusion of ADR-001 (Mesenchymal stem cell) in people with Glomerulonephritis , IGA, run by Nagoya University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: until 6 weeks after first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342325, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.