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IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
Primary IgA nephropathy (IgAN) is an immunopathological diagnostic term for a type of glomerulonephritis characterised by the deposition of IgA or IgA-dominant immune complexes in the glomerular tunica albuginea. And in China IgA nephropathy accounts for about 45% of primary glomerular diseases and about 26% of renal biopsies in patients with chronic failure. Among them, about 15-40% of IgA nephropathy patients progress to renal failure after 10-20 years; IgA nephropathy has become one of the main causes of end-stage renal failure.The nonsteroidal salicorticoid receptor antagonist (MRA)- finerenone reduces the risk of composite renal outcomes, ESKD, or renal death in patients with type 2 diabetes and CKD.There are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group: FINE+RASI group; | Patients treated with RASI and finerenone |
| |
| B group: RASI group; | Patients treated with RASI only |
| |
| C group: immune suppressive + FINE + RASI; | Patients receiving immunosuppressive drugs and RASIs |
| |
| D group: immune suppressive + RASI; | Patients receiving immunosuppressants, RASI and finerenone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone | Drug | Taking the maximum tolerated dose of finerenone based on serum creatinine and blood potassium levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage change in PCR from baseline to 6 months | Collect PCR data before enrolment and at month 6 and calculate the percentage change | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| percentage change in PCR from baseline to 1, 2 and 3 months | Collec PCR before enrolment and at months 1, 2 and 3, then calculate the percentage change | 1, 2 and 3 month |
| frequency of patients with a 30% and 50% decrease in PCR |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with IGA nephropathy by renal biopsy who met the inclusion exclusion criteria, were able to be followed up regularly, and had clinical follow-up data.
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| Name | Affiliation | Role |
|---|---|---|
| Qiaorui Wang, bachelor | Student | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy | Yiwu | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40357496 | Derived | Wang QR, Wu L, Huang J, Pan H, Wang XF, Li L, Han F, Wang YF, Wu ML, Yang Y. Efficacy and safety of finerenone in IgA nephropathy: an observational multicentre study. Clin Kidney J. 2025 Apr 28;18(5):sfaf125. doi: 10.1093/ckj/sfaf125. eCollection 2025 May. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2023 | Jun 5, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| RAS inhibitor | Drug | Receive RAS inhibitor treatment as specified in the KDIGO guidelines |
|
|
| Immune Suppressant | Drug | Receive immune suppressant treatment as specified in the KDIGO guidelines |
|
|
Calculate the number of patients with >30% or >50% reduction in proteinuria during the 6-month follow-up period
| 6 month |
| the level of change in eGFR | Collection of eGFR before enrolment and at months 6 | 6 month |
| the level of change in blood sodium | Collection of blood sodium before enrolment and at months 6 | 6 month |
| the level of change in serum creatinine | Collection of serum creatinine before enrolment and at months 6 | 6 month |
| the level of change in albumin | Collection of albumin before enrolment and at months 6 | 6 month |
| 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 |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |