ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease
7 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
161
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
KasrAlainy
-
Cairo, KasrAlainy, Egito, 11562
- Faculty of Medicine
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the progression or therapeutic response of diabetic kidney disease
Prazo: 12 months
|
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
|
12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de maio de 2024
Conclusão Primária (Real)
30 de agosto de 2025
Conclusão do estudo (Real)
28 de fevereiro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
5 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de agosto de 2026
Primeira postagem (Real)
11 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- N 379 2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .