A Phase 3 interventional study of Ramipril tablet and Amlodipine tablet in Endothelial Dysfunction, End-Stage Renal Disease and Pediatric Kidney Disease, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
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:
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:
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
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
Drug: Ramipril tablet
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
Drug: Amlodipine tablet
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
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
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: 1. Baseline: before initiation of antihypertensive treatment (Ramipril or Amlodipine) 2. 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.
Time frame: 1.Baseline: before initiation of antihypertensive treatment (Ramipril or Amlodipine) 2.End of treatment: at 3 months after completing the assigned treatment.
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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline At the end of treatment period (after 3 months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 63 phase 3 interventional studies under Kidney Failure, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 48. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ramipril · Amlodipine