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ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease

2026年8月7日 更新者:Mostafa Farouk、Cairo University

ABO/Rh Blood Group Phenotypes as Independent Predictor of Treatment Outcomes in Diabetic Kidney Disease: A 1-Year Prospective Cohort Study

Background and aim: ABO blood groups are biologically plausible modulators of endothelial function, coagulation, and inflammation - pathways central to diabetic kidney disease (DKD). This study evaluates whether ABO/Rh phenotypes associate with differential treatment outcomes in DKD.

Methods: This 1-year prospective cohort study enrolled 161 adults with type 2 diabetes and established DKD (all receiving ACE-I/ARB plus SGLT2 inhibitors) from Cairo University outpatient clinics. eGFR, ACR, HbA1c, lipids, electrolytes, and blood pressure were assessed at baseline and one year. Percent changes in eGFR and ACR were calculated and the Kidney Failure Risk Equation estimated 2- and 5-year risk of progressing to end stage kidney disease. Multivariable linear regression identified independent predictors of renal outcome changes.

研究概览

研究类型

观察性的

注册 (实际的)

161

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • KasrAlainy
      • Cairo、KasrAlainy、埃及、11562
        • Faculty of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

evident diabetic kidney disease defined as persistent albuminuria [Albumin/ creatinine ration (ACR) >30 mg/g Creatinine in two measurements with at least a 3-month difference], reduced eGFR (<60 mL/min/1.73 m²), or both and a documented history of type 2 diabetes mellitus for more than five years, as well as diabetic retinopathy classified according to the International Clinical Diabetic Retinopathy Scale of the American Academy of Ophthalmology

描述

Inclusion Criteria:

  • Adults aged ≥18 years with type 2 DM
  • Evident diabetic kidney disease
  • Recorded ABO blood group phenotypes
  • Receiving Angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARBs) in addition Sodium-glucose cotransporter 2 inhibitor (SGLT2i) as part of their ongoing therapy prior to enrolment.

Exclusion Criteria:

  • Pre-existed glomerular diseases or any other primary kidney disorder,
  • Active urinary sediment
  • Type 1 diabetes mellitus
  • Gestational diabetes
  • History of kidney transplantation
  • Documented episode of acute kidney injury,
  • Family history of non-diabetic forms of kidney disease
  • >30% declines in eGFR after initiation of RAAS inhibitors

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
A Rh+
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c
B Rh -
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c
B Rh +
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c
O Rh -
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c
O Rh +
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c
AB Rh -
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c
AB Rh +
ABO Rh subgroup
Random mid stream spot urine samples were collected in sterile containers, and albumin to creatinine ratio (ACR) was measured using the Roche Cobas chemistry analyzer. Albuminuria was categorized according to Kidney Disease Improving Global Outcomes (KDIGO) criteria as A1 (<30 mg/g), A2 (30-300 mg/g), and A3 (>300 mg/g) . The Kidney Failure Risk Equation (KFRE) was applied to estimate the predicted 2 year and 5 year risk of progression to end stage renal disease using baseline eGFR and ACR values . Percent change in both eGFR and ACR was calculated using the formula: ((Post - Pre) / Pre) × 100 . Significant (accelerated) DKD progression was defined as a ≥25% sustained decline in eGFR over 12 months or an annual loss of ≥15 mL/min/1.73 m² , while rapid eGFR decline was defined as a reduction >5 mL/min/1.73 m² per year; end stage renal disease was defined as eGFR <15 mL/min/1.73 m² or initiation of dialysis therapy . Albumin to creatinine ratio (ACR) response was c

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
the progression or therapeutic response of diabetic kidney disease
大体时间:12 months
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月1日

初级完成 (实际的)

2025年8月30日

研究完成 (实际的)

2026年2月28日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月7日

首次发布 (实际的)

2026年8月11日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年8月7日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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