NCT05942053RecruitingPhase 4
Role of Vitamin K2 in Chronic Kidney Disease
Clinical Study Evaluating the Role of Vitamin K2 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 Vitamin K2 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 vitamin K2 capsules once per day.The dose of ramipril may be modified according to blood pressure control. Group 2: Vitamin K2 (menaquinone-7) Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and vitamin K2 capsules (menaquinone-7) 90 mcg/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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 26 Jun 2023
- Start date
- 15 Jul 2023
- Primary completion date
- 14 Jul 2026
- Lead sponsor
- Tanta University
- Diseases
- Chronic kidney disease
- NCT number
- NCT05942053
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 44
- From 15 Jul 2023 to the primary completion date, 14 Jul 2026
- 1 site in 1 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 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 vitamin K2
Other illness
- 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.
Lab values
- 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.
Other
- Patients with an overactive thyroid gland.
- Pregnant and breastfeeding women.
- Patients with blood pressure ≥180/110 or \<100/60.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Pharmacy, Tanta University Coordinator of this site? Confirm its status | Tanta | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.