Evaluating Coenzyme Q10 for Chronic Kidney Disease Management

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 study is testing if adding Coenzyme Q10 to the usual treatment can help people with chronic kidney disease feel better and improve their kidney health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tanta University (other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Tanta, Capital of Gharbia Governorate.)
• Trial ID: NCT05942027 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Coenzyme Q10 as an additional treatment alongside ramipril in patients with chronic kidney disease (CKD) stages 2-3b. It is a randomized, placebo-controlled, double-blind study involving 44 non-dialysis CKD patients, focusing on outcomes such as blood pressure, proteinuria, and bone metabolism over a six-month period. Participants will be stratified and assigned to either the treatment or control group to assess the efficacy of Coenzyme Q10 in improving kidney health and related complications.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with non-dialysis chronic kidney disease stages 2-3b, an albumin-to-creatinine ratio of 30 mg/g or higher, and newly diagnosed hypertension.

Not a fit: Patients with diabetes, heart disease, or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option to improve kidney function and overall health in patients with chronic kidney disease.

How similar studies have performed: While the use of Coenzyme Q10 in chronic kidney disease is not extensively studied, preliminary findings suggest potential benefits, indicating this approach may be novel.

Eligibility criteria

Inclusion Criteria:

* 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 criteria:

* Patients with elevated level of potassium ≥ 5 mEq/L.
* 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 an overactive thyroid gland.
* Patients with bleeding disorder.
* History of drug allergy to ACEI or ARBs.
* Pregnant and breastfeeding women.
* Patients with blood pressure ≥180/110 or \<100/60.
* 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 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

Where this trial is running

Tanta, Capital of Gharbia Governorate.

• Faculty of Pharmacy Tanta University — Tanta, Capital of Gharbia Governorate., Egypt (RECRUITING)

Study contacts

• Study coordinator: Dina Abdel Hamid, Masters

Conditions: Chronic Kidney Diseases, Proteinuria, Bone Metabolism, Coenzyme Q10