A Phase 2/3 interventional study of Vitamin K1 and Vitamin k2 in End Stage Renal Disease on Dialysis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
Among 14 studies in Kidney Failure, Chronic by Ain Shams University — 3 open to participants now, 4 under way, 1 of them phase 3. Kidney Failure, Chronic · Ain Shams University.
Among the 14 studies in Kidney Failure, Chronic by Ain Shams University, this one is the 10th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2020, is one of 2 in phase 2/3, and was the 4th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →3 of the 14 studies in Kidney Failure, Chronic by Ain Shams University are open now, in 1 country. Recruiting first, the newest first:
Ain Shams University · Sites in Egypt
Ages 30–60 · Healthy volunteers
Ain Shams University
Ages 6–18
Ain Shams University
Ages 5–18
By country, each count listing its studies:
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 4 · Phase 4 1
First in 2014; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Median enrollment 60 across the 13 interventional studies, 100 across the 1 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
1 of the studies in Kidney Failure, Chronic by Ain Shams University that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07879560Phase 3Ain Shams UniversityRamipril vs. Amlodipine in Pediatric Hemodialysis Patients | 2027-10-01 |
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Among the 14 studies in Kidney Failure, Chronic by Ain Shams University, from their registry updates:
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To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.
Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease .
It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation .
Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries.
it is Prospective, Randomized,Placebo Controlled Study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
vitamin k1 will be given 10 mg thrice a week for 3 months
Drug: Vitamin K1
vitamin k2 (menaquinone) will be given 90 ug per day orally
Drug: Vitamin k2
placebo will be given daily per oral for 3 months
Other: placebo
vitamin k1 tablets
Also known as: Phylloquinone
vitamin k2 45 ug tablets twice daily
Also known as: menaquinone
placebo tablets
change in serum level of Uncarboxylated MGP
Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification
Time frame: change between baseline and after 3 months
parathyroid hormone
measuring change in serum PTH
Time frame: change between baseline and after 3 months
serum calcium level
measuring the change in serum calcium level
Time frame: change between baseline and after 3 months
serum phosphate level
measuring the change in phosphate level
Time frame: change between baseline and after 3 months
Plan to share: No
Ran from Jul 2020 to primary completion in Nov 2020, 3 months.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vitamin K 1 · Vitamin K 2