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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of Pharmacy Tanta University
RECRUITING
Tanta
Contact Information
Primary
Dina Abdel Hamid, Masters
pg_87899@pharm.tanta.edu.eg
+2001020198970
Time Frame
Start Date: 2023-07-15
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 44
Treatments
Placebo_comparator: 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.~Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov

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