Oxford Classification and Clinical Remission After Initial Treatments in Patients With IgA Nephropathy

Study Overview
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Brief Summary
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IgA nephropathy (IgAN) is the most common form of primary glomerulonephritis and one of the leading causes of end-stage renal disease in China. The clinical manifestations of IgAN varies widely among individuals, and renal pathology is crucial for determining the severity of renal damage and predicting the renal progression. However, the association between renal pathology and patient response to medication has not been reported, and the majority of earlier RCT studies have not taken renal pathology into consideration when enrolling patients. The Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group, one of the most prestigious kidney disease organizations in the world, claims that there is not enough evidence to support the use of Oxford Classification to decide whether to administer immunosuppressive therapy to patients with IgAN.Therefore, the goal of this study was to investigate the relationship between Oxford Classification and clinical remission rates following initial teatments in patients with IgAN, with the aim of providing a basis for individualized clinical treatment plans. This study was a single-center prospective cohort study, and patients who were hospitalized in Shenzhen Second People's Hospital from January 2011 to January 2021 and diagnosed as IgAN by renal biopsy were collected continuously and followed up until December 2022. Cox regression models were used to analyze the effect of different Oxford Classifications on the clinical remission rates of patients at 6, 12, 18, and 24 months of treatments, and the relationship between Oxford Classification and secondary outcome indicators such as long-term renal function and urinary protein changes were analyzed using generalized additive mixed models.

Official Title
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Oxford Classification and Clinical Remission After Initial Treatments in Patients With IgA Nephropathy：a Cohort Study

Conditions
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IgA Nephropathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years； Initial renal biopsy； Glomeruli>8； eGFR>15ml/min； Proteinuria/creatinine ratio（PCR）>0.5g/g Exclusion Criteria: Secondary IgAN Combined with other kidney diseases Combined with acute kidney injury Combined with tumor Followed-up time <6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mesangial hypercellularity, M<br>the histopathology was graded based on the revised Oxford Classification system as follows: M absent (M0) or M present (M1) | |
| endocapillary hypercellularity, E<br>E absent (E0) or E present (E1) | |
| segmental glomerulosclerosis, S<br>S absent (S0) or S present (S1) | |
| tubular atrophy/interstitial fibrosis, T<br>T ≤ 25% (T0) or T 26%-50% (T1), or T > 50% (T2) | |
| crescents, C<br>C absent (C0) or C present ≥ 1 glomerulus (C1) or C > 25% glomeruli (C2) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission rates (including complete and partial clinical remission rates) at 6, 12, 18, and 24 months for IgAN patients with different Oxford pathology scores (M, E, S, T, C) after being treated with the initial treatments. | Complete clinical remission: 24h urine protein <0.2g/d (or total urine protein/urine creatinine <0.2g/g) . Partial clinical remission: ≥50% decrease in urine protein from baseline and urine protein <1g/d (or total urine protein/urine creatinine <1g/g). | 6, 12, 18, and 24 months after being treated with the initial treatments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The longitudinal changes in renal function and urinary protein in IgAN patients with different Oxford Classification scores (M, E, S, T, C) after the initial treatments. | The rate of change in renal function: the estimated rate of change in glomerular filtration rate (eGFR). The rate of change of urine protein: the rate of change of total urine protein/urine creatinine. | During the follow-up period, the study will be terminated if the patient is transferred to renal transplantation, hemodialysis, peritoneal dialysis, or other centers, and the remaining patients will be followed until December 31, 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgA nephropathy, Oxford Classification, clinical remission rate