Kidney DiseaseNCT07757269
ABO/Rh Blood Group Phenotypes as Predictor of Treatment Outcomes in Diabetic Kidney Disease
An observational study of Kidney Disease, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease
- What is being tested?
- Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
- How many people
- 161 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 28 Feb 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Disease
- Being tested
- Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| A Rh+ | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium | |
| B Rh - | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium | |
| B Rh + | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium | |
| O Rh - | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium | |
| O Rh + | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium | |
| AB Rh - | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium | |
| AB Rh + | ABO Rh subgroup Receives: Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 May 2024
- Primary completion30 Aug 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farouk, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757269
- Sponsor's protocol ID
- N 379 2025
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABO/Rh Blood Group Phenotypes as Independent Predictor of Treatment Outcomes in Diabetic Kidney Disease: A 1-Year Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07757269
- Acronym / sponsor ID
- N 379 2025
- Conditions
- Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A Rh+ | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
| B Rh - | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
| B Rh + | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
| O Rh - | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
| O Rh + | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
| AB Rh - | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
| AB Rh + | – | Diagnostic Test: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumABO Rh subgroup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Pre-existed glomerular diseases or any other primary kidney disorder,
- Active urinary sediment
- Type 1 diabetes mellitus
- Gestational diabetes
- History of kidney transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassiumRandom 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 | Diagnostic test | A Rh+, AB Rh +, AB Rh -, B Rh +, B Rh -, O Rh +, O Rh - |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the progression or therapeutic response of diabetic kidney disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.