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Taking people in EgyptPhase 4

Tests coenzyme Q10 alongside ramipril in chronic kidney disease

Tests coenzyme Q10 added to ramipril in adults with chronic kidney disease.

Plain-language title generated from the registry record
Registry title: Role of Coenzyme Q10 in Chronic Kidney Disease

Key facts

Where
Tanta, EgyptSee the site
Phase
Phase 4

Where in Egypt

  • Faculty of Pharmacy, Tanta UniversityTanta, EgyptTaking people

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Trial details

Who runs it
Tanta University
Trial code
NCT05942027
Record updated
19 June 2025
Original description
This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium < 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups.Read full original descriptionShow less

Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients With Chronic Kidney Disease

This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium < 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups.

Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control.

Group 2: Coenzyme Q10 Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day. The dose of ramipril may be modified according to blood pressure control.

Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.

Inclusion: Age ≥ 18 years old; Both sexes; Patients matched in the duration of CKD; Non-dialysis chronic kidney disease (CKD) patient with estimated glomerular filtration rate (GFR) 30-89 mL/min/1.73m2 (Stage 2-3b); Patients with albumin-to-creatinine ratio ≥ 30 mg/g; Patients with serum Potassium < 5 mEq/L; A newly diagnosed patients with hypertension.

Exclusion: Patients on omega-3 fatty acids; vitamins (especially A, C, E, K), Chemotherapy and oral anticoagulant (warfarin), cholestyramine, orlistate will be excluded to avoid possible drug interactions that could affect Coenzyme Q10; Patients with diabetes; Patients with cancer; Patients with heart disease; Patients with hepato-biliary disease and other liver diseases; Patients with kidney stones and urinary tract infection; Patients with bleeding disorder; History of drug allergy to ACEI or ARBs; Patients with elevated level of potassium ≥ 5 mEq/L; Patients on alteplase, azothiopurine, everolimus, sirolimus, lithium, non-steroidal anti-inflammatory drugs (epifenac, tenoxicam, Celecoxib….), potassium retentive diuretics (amiloride, spironolactone), other ACEIs and ARBs will be excluded to avoid possible drug-drug interactions with ramipril; Patients with an overactive thyroid gland; Pregnant and breastfeeding women; Patients with blood pressure ≥180/110 or <100/60.

ClinicalTrials.gov NCT05942027