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New treatment option for Chronic Kidney Diseases
Official title Role of Vitamin K2 in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05942053
What this study is testing
What is Vitamin K 2?
Vitamin K 2 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Also referred to as menaquinone-7.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tanta, Capital of Gharbia Governorate., Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tanta, Capital of Gharbia Governorate., Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.