NCT05942053 Role of Vitamin K2 in Chronic Kidney Disease
| NCT ID | NCT05942053 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tanta University |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2023-07-15 |
| Primary Completion | 2026-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 44 participants in total. It began in 2023-07-15 with a primary completion date of 2026-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 vitamin K2
Contact & Investigator
Tarek Mostafa, PhD
PRINCIPAL INVESTIGATOR
Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt, 31527
Frequently Asked Questions
Who can join the NCT05942053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05942053 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05942053 currently recruiting?
Yes, NCT05942053 is actively recruiting participants. Contact the research team at pg_87899@pharm.tanta.edu.eg for enrollment information.
Where is the NCT05942053 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT05942053 clinical trial?
NCT05942053 is sponsored by Tanta University. The principal investigator is Tarek Mostafa, PhD at Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt, 31527. The trial plans to enroll 44 participants.
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