Endothelial DysfunctionPhase 3ADMA /PedsQLNCT07879560
Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients
A Phase 3 study testing Ramipril tablet and Amlodipine tablet in people with Endothelial Dysfunction and End-Stage Renal Disease, run by Ain Shams University.
Trial summary
The goal of this clinical trial is to learn if Ramipril works better than Amlodipine to reduce endothelial dysfunction in pediatric patients (aged 5-18 years) with end-stage kidney disease undergoing maintenance hemodialysis and diagnosed with hypertension. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Endothelial Dysfunction, End-Stage Renal Disease, Pediatric Kidney Disease
- What is being tested?
- Ramipril tablet and Amlodipine tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Phase 3
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged 5-18 years with end-stage kidney disease
- Patients must be undergoing regular maintenance hemodialysis for at least 3-6 months prior to enrollment.
- Only patients diagnosed with hypertension at baseline will be included in the study
Who cannot join
- Patients with infection within one month prior to enrollment.
- Patients with active malignancy
- Patients with pre-dialysis serum potassium levels ≥ 6.0 mEq/L within the previous three months.
- Patients with a known history of adverse reactions or hypersensitivity to ramipril or amlodipine.
- Patients with active connective tissue diseases. Patients with advanced liver disease.
- Patients with gastrointestinal dysfunction requiring parenteral nutrition.
- Patients with a history of myocardial infarction or cerebrovascular events within the previous three months.
- Patients with a history of ACE inhibitor-associated angioedema.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing The Efficacy and Safety of Ramipril Against Amlodipine on Endothelial Dysfunction in Pediatric Hemodialysis Patients
The goal of this clinical trial is to learn if Ramipril works better than Amlodipine to reduce endothelial dysfunction in pediatric patients (aged 5-18 years) with end-stage kidney disease undergoing maintenance hemodialysis and diagnosed with hypertension. It will also learn about the safety, efficacy, and impact on quality of life of both drugs. The main questions it aims to answer are:
- Does Ramipril lower asymmetric dimethylarginine (ADMA) levels-a marker of endothelial dysfunction-more effectively than Amlodipine?
- Does Ramipril preserve Fetuin-A levels-a marker of vascular calcification-better than Amlodipine?
- How effectively do Ramipril and Amlodipine control blood pressure and improve disease-specific quality of life?
- What side effects or medical problems do participants experience while taking Ramipril versus Amlodipine?
Read more
Researchers will compare Ramipril to Amlodipine to see if Ramipril exerts superior protective effects on vascular health and endothelial function beyond blood pressure reduction.
Participants will:
- Stop taking previous antihypertensive medications (ACE inhibitors or calcium channel blockers) for a 2-week washout period prior to baseline testing
- Take either Ramipril or Amlodipine daily for 3 months
- Continue standard hemodialysis sessions (3 times per week, 3-4 hours per session)
- Provide pre-dialysis blood samples at baseline and after 3 months of treatment
- Complete the Pediatric Quality of Life Inventory (PedsQL™ 3.0 ESRD) questionnaire at baseline and after 3-month
- Undergo regular blood pressure checks, clinical monitoring, and weekly phone check-ins to monitor safety and potential side effects
Read the detailed description
Chronic kidney disease (CKD) is a major global public health problem. Children with end-stage renal disease (ESRD) have markedly reduced life expectancy compared to healthy peers, primarily due to cardiovascular disease (CVD), which is the leading cause of excess mortality in this population, accounting for approximately 40-50% of all deaths.
Hypertension is one of the most prevalent comorbid conditions in children with chronic kidney disease and a major contributor to increased cardiovascular risk. Effective blood pressure control is essential; however, different classes of antihypertensive agents may exert distinct effects on vascular structure and function, influencing long-term cardiovascular outcomes beyond blood pressure reduction alone.
Ramipril is an angiotensin-converting enzyme inhibitor (ACEI) that acts through inhibition of the renin-angiotensin-aldosterone system, resulting in reduced angiotensin II levels, enhanced nitric oxide bioavailability, and attenuated oxidative stress and inflammation, which may improve endothelial function and mitigate adverse vascular remodeling, including vascular calcification.
Amlodipine is a calcium channel blocker (CCB) that primarily lowers blood pressure by inhibiting calcium influx into vascular smooth muscle cells, leading to vasodilation and reduced peripheral vascular resistance. While effective for blood pressure control, its impact on endothelial dysfunction and uremia-related vascular injury may differ from that of ACE inhibitors.
Both Ramipril and Amlodipine are effective antihypertensive agents commonly used in clinical practice. However, although both lower blood pressure, their effects on endothelial dysfunction, vascular calcification, and cardiovascular biomarkers may differ significantly due to their distinct mechanisms of action
- Being tested
- Ramipril tablet, Amlodipine tablet
- Keywords
- endothelial dysfunction, vascular calcification, ADMA, Fetuin A, PedsQL 3.0 ESRD, Blood Pressure, Ramipril, amlodipine
- Medical subject headings
- Kidney Failure, Chronic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril tabletDrug
Starting dose of (1.25 -2.5 mg ) oral once daily, with dose titration up to 5 mg/day according to blood pressure control and tolerability for 3 months
Amlodipine tabletDrug
2.5 mg oral once daily for patients weighing less than 30 kg and 5 mg once daily for patients weighing more than 30 kg, with dose titration up to 10 mg/day if clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Ramipril | Active comparator | Ramipril Tritace® : Starting dose of (1.25-2.5 mg ) oral once daily, with dose titration up to 5 mg/day according to blood pressure control and tolerability for 3 months Receives: Drug: Ramipril tablet |
| Amlodipine | Active comparator | Amlodipine Norvasc®: 2.5 mg oral once daily for patients weighing less than 30 kg and 5 mg once daily for patients weighing more than 30 kg, with dose titration up to 10 mg/day if clinically indicated for 3 months Receives: Drug: Amlodipine tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum asymmetric dimethylarginine (ADMA) level as a marker of endothelial dysfunction
Endothelial dysfunction marker:
Serum asymmetric dimethylarginine (ADMA) level
Blood samples will be collected from each patient at two predefined time points throughout the study:
- Baseline: before initiation of antihypertensive treatment (Ramipril or Amlodipine)
- End of treatment: at 3 months after completing the assigned treatment. Blood samples will be drawn prior to the hemodialysis session, centrifuged, and stored at -80 °C until analysis. Serum levels of ADMA will be measured using enzyme-linked immunosorbent assay (ELISA) techniques.
Measured: 1.Baseline: before initiation of antihypertensive treatment (Ramipril or Amlodipine) 2.End of treatment: at 3 months after completing the assigned treatment.
Secondary outcomes (3)
Serum Fetuin-A level as a marker of vascular calcification.
Serum Fetuin-A will be assessed at baseline and at the end of treatment (3 months) using ELISA kits, following the same sampling and storage procedures as ADMA.
Measured: 1.Baseline: before initiation of antihypertensive treatment (Ramipril or Amlodipine) 2.End of treatment: at 3 months after completing the assigned treatment.
Blood pressure control
Systolic and diastolic blood pressure will be measured before dialysis sessions.
Blood pressure readings will be recorded at baseline and throughout the 3-month treatment period, and mean values will be used for analysis to evaluate the antihypertensive efficacy of Ramipril and Amlodipine.
Measured: throughout the 3-month treatment period
Quality of life (QOL)using the Pediatric Quality of Life Inventory (PedsQL) 3.0 End Stage Renal Disease (ESRD) Module
Quality of life will be assessed using the validated Arabic version of the Pediatric Quality of Life Inventory™ 3.0 End-Stage Renal Disease Module (PedsQL™ 3.0 ESRD), which is specifically designed for use in children and adolescents with end-stage renal disease undergoing dialysis.
The questionnaire will be administered:
At baseline At the end of treatment period (after 3 months) Quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 End Stage Renal Disease (ESRD) Module. Items are rated on a 5-point scale ranging from 0 to 4 (0 = Never / no problem, 1 = Almost never, 2 = Sometimes, 3 = Often, 4 = Almost always / greatest problems). Items are reverse-scored and transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0). Total and domain scores are calculated as the mean of the transformed items, with final scores ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life.
Measured: At baseline At the end of treatment period (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly using permuted block randomization assigned in a 1:1 ratio to receive either: Group A (Ramipril) Tritace® : Starting dose of (1.25 - 2.5 mg) once daily, with dose titration up to 5 mg/day based on blood pressure control and tolerability. Group B (Amlodipine) Norvasc®: Dose of 2.5-5 mg once daily according to body weight, with dose titration up to 10 mg/day if clinically indicated. Each participant will remain on the assigned treatment throughout the study duration (3 months) without crossover to the alternative treatment.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nafesa Ahmed, Ain Shams University
- Investigators
- Nafesa A Mohamed Rashad, Teaching Assistant, Principal investigator, Clinical Pharmacy Department, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science and Technology (MUST), 6th of October City, Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879560
- Sponsor's protocol ID
- RAM-AML-2026
- Acronym
- ADMA /PedsQL
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No