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

NCT07757269 | Completed

• 1 other identifier: N 379 2025
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Disease

Outcome Measures

Primary Outcomes (1)

• the progression or therapeutic response of diabetic kidney disease

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

  12 months

Study Arms (7)

A Rh+

ABO Rh subgroup

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

B Rh -

ABO Rh subgroup

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

B Rh +

ABO Rh subgroup

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

O Rh -

ABO Rh subgroup

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

O Rh +

ABO Rh subgroup

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

AB Rh -

ABO Rh subgroup

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

AB Rh +

ABO Rh subgroup

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

Interventions

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

A Rh+; AB Rh +; AB Rh -; B Rh +; B Rh -; O Rh +; O Rh -

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine

Cairo, KasrAlainy, 11562, Egypt

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: May 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: February 28, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

EG (1)