NCT07879560Not yet recruitingPhase 3
Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients
Comparing The Efficacy and Safety of Ramipril Against Amlodipine on Endothelial Dysfunction in Pediatric Hemodialysis Patients
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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? 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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Ain Shams University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07879560
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 50
- From 1 Nov 2026 to the primary completion date, 1 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with infection within one month prior to enrollment.
- Patients with a history of myocardial infarction or cerebrovascular events within the previous three months.
Other illness
- Patients with active malignancy
- 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 a history of ACE inhibitor-associated angioedema.
Lab values
- Patients with pre-dialysis serum potassium levels ≥ 6.0 mEq/L within the previous three months.
Other
- Patients with gastrointestinal dysfunction requiring parenteral nutrition.
Who the study is looking for
- 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
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.