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临床试验/NCT05528991
NCT05528991招募中不适用

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

Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 474 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
474
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥18 years;
  • Initial renal biopsy;
  • Glomeruli>8;
  • eGFR>15ml/min;
  • Proteinuria/creatinine ratio(PCR)>0.5g/g

排除标准

  • Secondary IgAN
  • Combined with other kidney diseases
  • Combined with acute kidney injury
  • Combined with tumor
  • Followed-up time <6 months

结局指标

主要结局

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.

时间窗: 6, 12, 18, and 24 months 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).

次要结局

  • 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.(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)

研究者

发起方
Shenzhen Second People's Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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