Vitamin K1 to Slow Progression of Vascular Calcification in HD Patients

• Status: Terminated
• Trial end date: 2020-07-17
• Target enrollment: 0
• Participant gender: All

Summary

Patients on hemodialysis (HD) exhibit an immensely increased cardiovascular mortality associated with extensive vascular calcification (VC). In the past years the development of VC was discovered to be actively regulated and as being influenced by inhibitors of calcification (e.g. matrix-Gla-protein, fetuin-A). MGP is produced by vascular smooth muscle cells and needs post-translational modification by vitamin K dependent gamma-carboxylation to be fully active. Based on the demonstration of increased PIVKA-II levels, about 97% of all HD patients exhibit insufficient carboxylation activity. We therefore aim in this randomized, controlled study to retard the progress of coronary and aortal calcification as assessed by thoracic multislice-CT by the thrice weekly administration of 5 mg vitamin K1 (phylloquinone) to about 100 HD patients over a period of 18 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Treatments: Vitamin K; Vitamin K 1; Vitamins

Criteria

Inclusion Criteria:

• Male or Female minimum 18 years of age

• Not less than 6 months on hemodialysis

• Cardiovascular calcification percent (coronary artery volume score > 100)

• Written consent to take part in the study

• Life expectancy not less than 18 months

Exclusion Criteria:

• Known hypersensitivity against Vitamin K1

• History of thrombosis

• intake of Vitamin K

• tumor disease

• pulse >100/min (resting heart rate)

• Intake of vitamin K antagonists (e.g. Marcumar) at baseline or in the 3 months prior to baseline

• Inflammatory bowel disease

• Short-bowel syndrome

• Significant liver dysfunction

• more than one stent in one coronary artery plus one or more stents in an additional artery

• Hemoglobin < 70 g/L

• Women who are pregnant or breastfeeding

• Women without sufficient contraception

• Alcohol or drug abuse

• Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study

• Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up-visits and unlikelihood of completing the study

• Participation in a parallel clinical trial or participation in another clinical trial within the previous 3 months

• Subjects who are in any state of dependency to the sponsor or the investigators

• Employees of the sponsor or the investigators

• Subjects who have been committed to an institution by legal or regulatory order