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

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.

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Key information

Conditions

Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine

Cairo, KasrAlainy, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium

Diagnostic Test

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

Primary outcomes

the progression or therapeutic response of diabetic kidney disease

Time frame: 12 months

assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Aug 11, 2026
Registry last updated: Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed