- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07757269
ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
KasrAlainy
-
Cairo, KasrAlainy, Egypti, 11562
- Faculty of Medicine
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
the progression or therapeutic response of diabetic kidney disease
Aikaikkuna: 12 months
|
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
|
12 months
|
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