ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease
7 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Наблюдательный
Регистрация (Действительный)
161
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
KasrAlainy
-
Cairo, KasrAlainy, Египет, 11562
- Faculty of Medicine
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
the progression or therapeutic response of diabetic kidney disease
Временное ограничение: 12 months
|
assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups
|
12 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 мая 2024 г.
Первичное завершение (Действительный)
30 августа 2025 г.
Завершение исследования (Действительный)
28 февраля 2026 г.
Даты регистрации исследования
Первый отправленный
5 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
7 августа 2026 г.
Первый опубликованный (Действительный)
11 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- N 379 2025
Планирование данных отдельных участников (IPD)
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НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .