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

7 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

161

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Egypte
    • KasrAlainy
      • Cairo, KasrAlainy, Egypte, 11562
        • Faculty of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
A Rh+
ABO Rh subgroup
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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
Test diagnostique: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
the progression or therapeutic response of diabetic kidney disease
Délai: 12 months
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2024

Achèvement primaire (Réel)

30 août 2025

Achèvement de l'étude (Réel)

28 février 2026

Dates d'inscription aux études

Première soumission

5 août 2026

Première soumission répondant aux critères de contrôle qualité

7 août 2026

Première publication (Réel)

11 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • N 379 2025

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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