ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease
7 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
161
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
KasrAlainy
-
Cairo, KasrAlainy, Egipto, 11562
- Faculty of Medicine
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the progression or therapeutic response of diabetic kidney disease
Periodo de tiempo: 12 months
|
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
|
12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2024
Finalización primaria (Actual)
30 de agosto de 2025
Finalización del estudio (Actual)
28 de febrero de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2026
Publicado por primera vez (Actual)
11 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- N 379 2025
Plan de datos de participantes individuales (IPD)
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INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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