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

7. august 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

161

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
A Rh+
ABO Rh subgroup
Diagnostisk test: 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
Diagnostisk test: 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
Diagnostisk test: 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
Diagnostisk test: 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
Diagnostisk test: 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
Diagnostisk test: 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
Diagnostisk test: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
the progression or therapeutic response of diabetic kidney disease
Tidsramme: 12 months
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
12 months

Samarbeidspartnere og etterforskere

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Sponsor

Cairo University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2024

Primær fullføring (Faktiske)

30. august 2025

Studiet fullført (Faktiske)

28. februar 2026

Datoer for studieregistrering

Først innsendt

5. august 2026

Først innsendt som oppfylte QC-kriteriene

7. august 2026

Først lagt ut (Faktiske)

11. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • N 379 2025

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Nei

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